FALL 2020/WINTER 2021 ISSUE

Transplant and Cellular Immunotherapy NEWS

The Immunotherapy Program at Northside Hospital Cancer InstituteBy: Melhem Solh, MD

The immune system, in addition to fighting infections, plays a key role in preventing cancer from occurring by identifying abnormal cells and destroying them before they develop into active malignancy. It is the ability of some of these cells to evade the immune system attack that results in patients developing cancers. Cancer immunotherapy works by boosting, re-training or engineering the patient’s immune system to be more efficient at fighting cancer. Recent advances in immunotherapy provide a road map to treat and potentially cure refractory cancers, especially blood cancers and a hope that some day to be the mainstay of cancer treatment.

The Immunotherapy Program at Northside was established to provide patients in Georgia and surrounding states access to cutting-edge clinical research trials as well as commercially available immunotherapies. The mission of this Northside Cancer Institute Program is to provide exceptional care and superior survival outcomes. The program brings together expert Northside physicians in all areas of cancer sub-specialties, supported by a team of patient coordinators, nurses, midlevels, research staff, health psychologists, dietitians, physical and occupational therapists, immune cell collection and processing facility and a nationally recognized blood and marrow transplant team to provide a collaborative approach for rapid implementation of scientific advances in cancer immunotherapy.

In addition to being a certified center for the FDA-approved chimeric antigen receptor (CAR) T-cell therapies (Kymriah®, Tecartus™, and Yescarta®), the program has several ongoing immunotherapy trials ranging from conjugate antibodies, bispecific T cell engagers, CAR T-cell therapies (autologous and allogeneic), virus specific T cells, multi tumor-associated antigen T cells and natural killer (NK) cell therapies that encompass a variety of malignant and infectious etiologies including acute leukemias, multiple myeloma and lymphomas and COVID-19.

Please review our immunotherapy clinical research trials. If you have a question regarding study eligibility, please contact Stacey Brown, Northside BMT/Leukemia clinical research manager, at 404.780.7965 or stacey.brown@northside.com.

IN THIS ISSUE:

p3 Dr. Scott Solomon Co-Authors Novel Clinical Research CAR T-Cell Peer Reviewed Article

The Northside Hospital BMT Difference

CAR T-Cell Outpatient Infusion Is Now Available

p4 More CAR T-Cell Therapies Available at the Immunotherapy Program at Northside Hospital

Northside Hospital BMT Ranks Among National Leaders in Allogeneic Transplantation

p5 Congratulations to Our Data Management Team for Continuously Providing Outstanding Data to CIBMTR and BMT CTN

p6 Dr. Melhem Solh Presented Current Updates in Myelodysplastic Syndromes (MDS) at the 2020 Virtual 2020 Blood Cancer Georgia Conference

2020 Castle Connolly Top Doctor Awards

2019 Northside Hospital BMT Program Survivor Reunion Draws Over 600 Participants

p7 BMT/Leukemia Protocols

Disease Trial Number Name of Trial Drug & Link to

clinicaltrials.gov

Immunotherapy

NHL NSH1170 A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells, in Relapsed and Refractory (r/r) B-Cell Non-Hodgkin Lymphoma

JCAR017 NCT02631044

NSH1226 An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

JCAR017 NCT03331198

NSH1231 Managed Access Program (MAP) to Provide Access to CTL019, for Acute Lymphoblastic Leukemia (ALL) or Large B-cell Lymphoma Patients Without Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification for Commercial Release

CTL019 NCT03601442

(continued on page 2)

Ongoing Immunotherapy Clinical Trials

2 | FALL 2020/WINTER 2021 ISSUE Transplant & Cellular Immunotherapy NEWS

Disease Trial Number Name of Trial Drug & Link to

clinicaltrials.gov

Immunotherapy

NHL NSH 1251 A Phase 1, Multicenter, Open-Label Study of CC-97540, C19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

CC-97540 NCT04231747

NSH1259 A Phase 2, Open-Label , Single-Arm Study to Evaluate the Efficacy and Safety of Camidaniumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma

ADCT-301 NCT04052997

NSH1261 A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XMAB13676 in Patients with CD20-Expressing Hematologic Malignancies

XMAB13676 NCT02924402

NSH1270 A Phase 1/2a, Open-Label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

PBCAR0191 NCT03666000

NSH1282 (Open Jan 2021)

Expanded Access Protocol (EAP) for Patients Receiving Lisocabtagene Maraleucel that is Nonconforming for Commercial Release

Lisocabtagene Maraleucel NCT04400591

NSH1297 (Open Jan 2021)

A Phase 1/ 2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma

Loncastuximab Tesirine and Ibrutinib NCT03684694

Multiple Myeloma

NSH1216 A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (rrMM) (KarMMa-3)

bb2121 NCT03651128

NSH1224 A Phase I, Open Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic and Clinical Activity of PF-06863135, A B-Cell Maturation Antigen (BCMA) – CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Advanced Multiple Myeloma (MM)

PF-06863135 NCT03269136

NSH1277 (Open Jan 2021)

A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects with High-Risk Newly Diagnosed Multiple Myeloma (KarMMa-4)

bb2121 NCT04196491

NSH1298 (Open March 2021)

Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That Is Non-Conforming for Commercial Release bb2121-EAP-001

bb2121-EAP-001

AML/MDS NSH1296 (Open April 2021)

Phase 1 Study of Escalating Single and Multiple Doses of Mana 312 (Multi Tumor-Associated Antigen T Cells) Administered to Adult Subjects with AML or MDS after Allogeneic Hematopoietic Stem Cell Transplant

Mana

C394 (Open Dec 2020)

BMT CTN 1803 Haplo-Identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS

NCT04395092

ALL NSH1231 Managed Access Program (MAP) to Provide Access to CTL019, for Acute Lymphoblastic Leukemia (ALL) or Large B-cell Lymphoma Patients Without Specification Leukapheresis Product and/or KManufactured Tisagenlecleucel Out of Specification for Commercial Release

CTL019 NCT03601442

NSH1270 A Phase 1/2a, Open-Label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

PBCAR0191 NCT03666000

SLL/CLL NSH1226 An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

JCAR017 NCT03331198

Hematological Malignancies

NSH1164 A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic Malignancies

XmAB® 14045 NCT02730312

Hemorrhagic Cystitis

C429 (Open March 2021)

A Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients with Virus-Associated Hemorrhagic Cystitis after Allogeneic Hematopoietic Cell Transplant

ALVR105 NCT04390113

Respiratory Viruses

C434 (Open Spring 2021)

Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 for the Treatment of High-Risk Patients with Respiratory Viral Infections after Hematopoietic Cell Transplant

ALVR105

Ongoing Immunotherapy Clinical Trials (continued from page 1)

3FALL 2020/WINTER 2021 ISSUE |Northside Hospital Blood & Marrow Transplant Program

Dr. Scott Solomon Co-Authors Novel Clinical Research CAR T-Cell Peer Reviewed Article

CAR T-Cell Outpatient Infusion Is Now Available

The Immunotherapy Program at Northside Hospital participated in a pivotal clinical research trial entitled, “A global randomized, multicenter phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).” Study results were recently published in the peer-reviewed medical journal Lancet.

Major highlights of the study were: • Complete response (CR): 53%, 65% of which maintained past one year • Cytokine release syndrome (CRS): median five days, grade 3/4 in 2% • Immune effector cell-associated neurotoxicity syndrome (ICANS): median nine days, grade 3/4 in 9% • Prolonged grade 3/4 cytopenias past day 29 in 37%

We thank all of our patients and staff members who participated in this important clinical research trial.

Chimeric antigen receptor (CAR) T-cell therapies are at the forefront of adoptive cell transfer therapies, in which patients’ own immune cells are utilized to treat their cancer. With autologous CAR T-cell therapy, the patient’s blood is collected, and T cells are then genetically modified and reinfused into the patient. The use of adoptive cell therapy after administration of an immunodepleting preparative regimen has been shown to provide curative potential for otherwise refractory blood malignancies.

CAR T-cell therapies are currently administered at a limited number of Foundation for the Accreditation of Cellular Therapy (FACT) accredited cancer centers, are primarily delivered in an inpatient setting and require a post-infusion admission for several days. Patients may experience an exaggerated immune response known as cytokine release syndrome (CRS), which could result in significant morbidity and mortality if not diagnosed and treated promptly. However, ongoing clinical experience has provided the safety and feasibility of administering CAR T-cell therapy as an outpatient process in clinical practices. Not all CAR T-cell products are the same and therefore have varying toxicity profiles. A true assessment of the appropriate setting for the administration of a patient’s cellular therapy is dependent upon the CAR T-cell product utilized, patient disease status, availability of caregivers to ensure specific safety requirements for the safe administration and monitoring of the patient and the experience of the center providing treatment.

The Immunotherapy Program at Northside Hospital is currently offering several CAR T-cell therapy outpatient infusions, where the patient is followed on a daily basis in the outpatient clinic. This transition mirrors our current autologous and allogeneic hematopoietic stem cell transplant therapy program. The patient must be an approved candidate for outpatient therapy with an available caregiver to provide daily outpatient visits as well as live close to the treatment center in the event he or she needs to be quickly admitted if signs of CRS or neurotoxicity symptoms develop.

Post-infusion, close monitoring of the patient is required to assess for any complications. CAR T-cell therapies are not all the same and may have varying degrees of side effects and toxicities. Patients and family/caregivers must fully understand the specific side effect profile for the CAR T-cell product administered. Caregivers

The Northside Hospital BMT Difference

• Only attending BMT physicians take calls after hours and on weekends. • All BMT physicians focus on clinical patient care year-round. • Outpatient based allogeneic transplant program has been shown to improve survival outcomes. • Dedicated specialty designed 56-bed inpatient HEPA filtered unit • High ratio of BMT trained pharmacists-to-patients • Outstanding re-accreditation with the Foundation of Accreditation for Cellular Therapy (FACT) with no clinical deficiencies for the last six consecutive tri-annual inspections

(continued on page 4)

4 | FALL 2020/WINTER 2021 ISSUE Transplant & Cellular Immunotherapy NEWS

TECARTUS™ (brexucabtagene autoleucel), a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell), is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.1,2

YESCARTA®, axicabtagene ciloleucel, is a CD19-directed genetically modified autologous T cell immunotherapy and first FDA-approved CAR T-cell therapy for adult patients with certain types of non-Hodgkin lymphoma (NHL) who have relapsed or refractory disease after receiving two or more types of treatment.4

KYMRIAH® is a CD19-directed genetically modified autologous T cell immunotherapy to treat adult patients with two types of blood-derived cancers: patients up to the age of 25 with a diagnosis of B-cell acute lymphoblastic leukemia (ALL) that is refractory or in a second or greater relapse and adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.3

References: 1. BusinessWire.com Press Release. Kite submits biologics license application to U.S. Food and Drug Administration for company's second CAR T cell therapy. https://www.businesswire.com/news/home/20191211005861/en/. Published December 11, 2019. Accessed June 15, 2020. 2. TECARTUS™. Package insert. Kite Pharma, Inc; 2020.3. KYMRIAH®. Package insert. Novartis Pharmaceuticals Corporation; 2018.4. YESCARTA®. Package insert. Kite Pharma, Inc; 2020.

early management of any complications. If a patient develops serious side effects, hospital admission will be required. The potential for a hospital admission will be planned, so the patient can be fast-tracked to a designated bed.

For select hematologic malignancies, CAR T-cell therapy has succeeded where conventional therapies have failed. The Immunotherapy Program at Northside continues to offer hope to patients who have exhausted all other treatment options, ushering in a new era of cancer treatment.

Northside Hospital BMT Ranks Among National Leaders in Allogeneic TransplantationFor the eleventh consecutive year (2009-19), Northside BMT achieved survival outcomes that significantly exceeded the expected range as reported in the Center for International Blood and Marrow Transplant

Research (CIBMTR) Final 2019 Transplant Center Specific Survival Report, December 16, 2019 and from reported outcome data from Be The Match®.

(continued on page 5)

More CAR T-Cell Therapies Available at the Immunotherapy Program at Northside HospitalWe are pleased to announce additional treatment options are now available at the Immunotherpy Program at Northside Hospital. TECARTUS™ (brexucabtagene autoleucel), the first and only FDA-approved CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell), is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

This indication was approved under accelerated approval based on overall response rate and durability of response.1,2

Northside is also an FDA-approved CAR T-cell center offering several additional products as shown in the table on the next page. Please call 404.255.1930 to speak with a physician or to refer a patient.

should receive education to assess for changes in cognition and other potential neurological toxicities. The seriousness of any toxicity should be reported early and evaluated immediately, as the intensity of the toxicity can escalate quickly in some cases. Close care coordination with the patient, family/caregivers and health care team is absolutely essential. Patients who receive CAR T-cell therapy with intent for outpatient follow-up will have 24/7 access to one of the BMT physicians specializing in the specific therapeutic disease area and trained in the management of patients receiving cellular therapies, who can diagnose and begin

CAR T-Cell Outpatient Infusion Is Now Available (continued from page 3)

5FALL 2020/WINTER 2021 ISSUE |Northside Hospital Blood & Marrow Transplant Program

EXCEPTIONAL TRANSPLANT PERFORMANCE YEAR-AFTER-YEAR

1 of Only 2 Adult Programs in the nation that has achieved survival

expected survival rate for the last 11 consecutive reporting cycles.*

11 Consecutive Years Exceeding survival rates in

allogeneic transplants.

11

Northside Actual Rates**

U.S. ExpectedRates

2019 Survival Rates81.1%

63.3-73.6%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Northside Hospital BMT Ranks Among National Leaders in Allogeneic Transplantation (continued from page 4)

Congratulations to Our Data Management Team for Continuously Providing Outstanding Data to CIBMTR and BMT CTNIn 2020, our program underwent two external quality data audits: CIBMTR (Center for International Blood and Marrow Transplant Research) and BMT CTN (Blood and Marrow Transplant Clinical Trial Network). Both audits resulted in error rates lower than the national standard.

External Quality Reports: CIBMTR Data Audit

CIBMTR: Center for International Bone Marrow Transplant Research- All US transplant programs are required to submit data for

autologous, allogeneic and other cell therapy

- Centers are audited every 4 years for critical data fields

- Program audited March 2-5, 2020 over 7000 critical data fields with a 0.8% error rate

- 5th consecutive data quality audit by CIBMTR with a critical field error rate of less than 3%.

3%

0%

1%

2%

3%

4%

CIBMTR goal BMT NH error rate

0.80%

“The BMT Program at Northside is the largest allogeneic transplant program in Georgia,” said H. Kent Holland, MD, medical director of the BMT Program at Northside Hospital Cancer Institute. “Our success is a direct reflection of the combined experience and expertise of the teams in our inpatient and outpatient BMT units, our stem-cell laboratory and blood donor center.”

Innovative treatments and research are major components of the BMT Program at Northside, which includes chimeric antigen receptor (CAR) T-cell therapy and other immunotherapy treatment options as well as novel clinical research trials.

One hundred seventy adult and pediatric transplant centers were included in the analysis of patients who received their first allogeneic transplant between January 1, 2015 and December 31, 2017 using unrelated or related donors and who had reported follow-up. The one-year survival of patients transplanted at Northside Hospital was 81.1%.*

Northside BMT is one of only two adult BMT programs in the U.S. that achieved survival outcomes that significantly exceeded their expected survival rate for the last 11 consecutive reporting cycles, and Northside BMT is the only program in Georgia to overperform.

RREESSEEAARRCCHH UUPPDDAATTEESS

Blood and Marrow Transplant Clinical Trial Network (BMTCTN) CORE CENTER

Awarded in 2011 from National Cancer Institute (NCI)

1 of 20 centers in nation and the only lead

consortium site in GA

Re-selected in 2017 as the lead site of a

consortium through a competitive grant

process

2019 Center Performance Report

Rating = 98% “Outstanding”

HighlightsDr. Bashey: Donor

Selection CommitteeDr. Solh: BMTCTN

1703 Protocol Team

BMTCTN Goals Scientific/Administrative

AccrualActivation and Enrollment Data and Lab Compliance

6 | FALL 2020/WINTER 2021 ISSUE Transplant & Cellular Immunotherapy NEWS

2020 Castle Connolly Top Doctor Awards

2019 Northside Hospital BMT Program Survivor Reunion Draws Over 600 Participants

We are proud to announce our five BMTGA physicians were selected as 2020 Castle Connolly Top Doctor recipients and were recently featured in the New York Times. We congratulate our dedicated physicians.

On October 12, 2019, over 600 survivors, caregivers, physicians and staff attended the 2019 Northside BMT Survivor Reunion held at Mercedes Benz Stadium. Survivors from one year post-transplant to 22 years post-transplant attended the reunion. We thank everyone who made the reunion a success.

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The physicians in this ad have been previously selected as Castle Connolly Top Doctors for past and current publications. While they have paid for their inclusion in today’s advertisement, they do not and cannot pay to be named as a Castle Connolly Top Doctor.For further information, contact Lin Waterford, Manager of Physician Relations & Program Support, at lwaterford@castleconnolly.com To learn more about the Top Doctors included in this ad and other Top Doctors, visit www.castleconnolly.comCastle Connolly, the publisher of Castle Connolly Top Doctors® guides and the online database at www.castleconnolly.com, is America’s original, authentic and most trusted source for identifying Top Doctors. Beware of imitators who may not apply the same high standards in their physician research and selection processes.Only if you see the Castle Connolly name can you be certain that you are benefiting from their two decades of expertise, experience and commitment to help consumers find the best in American medicine. All licensed MDs and DOs are invited to nominate their peers for consideration as a Castle Connolly Top Doctor by visiting www.castleconnolly.com/nominations

Upper East Side Cardiology

www.BhusriHeart.com

Board Certified in: Cardiovascular Disease, Adult Comprehensive Echocardiography, Internal MedicineSocieties: American College of Cardiology and American Heart AssociationSpecial Expertise: Acute Cardiac Care; Clinical Cardiology; Echocardiography; Nuclear Cardiology; Electrocardiography; Stress Testing; Holter Monitoring; Coronary Artery Disease; Peripheral Vascular Disease; Hypertension; Vascular Imaging & Interpretation; Arrhythmias; Complex Anticoagulation; Heart Failure; Valvular Disease; Preventative Cardiology; Internal Medicine

Waldorf Dermatology Aesthetics57 N. Middletown RdNanuet, NY 10954845-623-7077

waldorfderm.com @drheidiwaldorfBoard Certified in: DermatologyHospital Affiliation: The Mount Sinai HospitalSpecial Expertise: Natural Non-invasive Rejuvenation Face & Body, Fillers, Botox, Fraxel, Kybella, Thermage, Ultherapy, Silhouette Lift, PRP for Hair Loss, Coolsculpting, Emsculpt, Emtone, Treatment Brown/Red Spots, Wrinkles, Scars & Skin Care, Hydrafacial, Clear & Brilliant, Microdermabrasion

Sasson Plastic Surgery1000 Northern Blvd. Suite 370 Great Neck, NY 11021516- 487-5017

SassonPlasticSurgery.comBoard Certified in: Plastic SurgeryHospital Affiliation: Chief of Plastic Surgery at Northwell Plainview and LIJ-VS Hospitals; Mount Sinai West, Mount Sinai St. Luke’s, Lenox Hill & NYU WinthropSpecial Expertise: Cosmetic and Reconstructive Surgery for Men, Women & Childern; Rhinoplasty, Face, Eyes & Breast; Tummy Tuck & Facial Rejuvenation

New York Center for Facial Plastic and Laser Surgery630 Park AvenueNew York, NY 10065212-570-2500

newyorkfacialplasticsurgery.com Board Certified in: Facial Plastic and Reconstructive Surgery Hospital Affiliations: Lenox Hill Hospital, Manhattan Eye, Ear and Throat Hospital, New York Eye and Ear Infirmary of Mount Sinai and North Shore University Hospital, Manhasset Faculty Appointment: Associate Clinical Professor, Facial Plastic Surgery, Albert Einstein College of MedicineSpecial Expertise: Minimally Invasive Facelifts, Eyelid Lifts and Rhinoplasty

Mount Sinai Heart1190 Fifth Avenue – 1 SouthNew York, NY 10029212-241-0884

Long Island Plastic Surgical Group999 Franklin AveGarden City, NY 11530516-962-2271www.lipsg.com

5670 Peachtree Dunwoody Road Suite 1000Atlanta, GA 30342404-255-1930 www.BMTGA.com

Board Certified in: Plastic SurgeryHospital Affiliations: NYU Langone Health - NYU Winthrop Hospital, St. Francis Hospital - The Heart CenterSocieties: American Burn Association, American College of Surgeons, American Society of Plastic Surgery, American Society for Peripheral Nerve, Canadian Society of Plastic SurgeonsSpecial Expertise: Breast Augmentation, Liposuction, Tummy Tuck, Peripheral Nerve Reconstruction, Maxillofacial Reconstruction

Hospital Affiliation: Northside Hospital AtlantaRecent Accolades: National Leaders in Allogeneic Blood and Marrow TransplantationSpecial Expertise: Acute Leukemia, Blood and Marrow Transplant, CAR T-Cell Immunotherapy and Clinical Research H. Kent Holland, MDAsad Bashey, MD, PhDMelhem Solh, MD

Scott Solomon, MDLarry Morris, MD

Franklin Lakes, Glen Rock, Westwood, Paramus, North Bergen, Garfield, Paterson, Union City, Wyckoff and Stony Point (NY) 844-777-0910

www.kayalortho.comBoard Certified in: ABOS, AAOSHospital Affiliations: Hackensack Meridian Health - HUMC, Hackensack Meridian Health Pascack Valley Medical Center, The Valley Hospital, Chilton Medical Center, Hudson Regional Hospital Special Expertise: Robotic/Custom Partial and Total Joint Replacements, Sports Medicine and Arthroscopy

Ainsworth Institute of Pain Management 115 East 57th Street, Suite 1210 New York, NY 10022 212-203-2813

www.Ainsworthinstitute.comBoard Certified in: Physical Medicine & Rehabilitation, Pain Management Hospital Affiliations: Mount Sinai Hospital, Mount Sinai West, Mount Sinai Downtown, Lenox Hill HospitalSpecial Expertise: Low Back Pain, Pelvic Pain, Amputee Pain, Facial Pain/Headaches, Complex Regional Pain Syndrome, Neuropathy, Spinal Stenosis, Spinal Cord and Dorsal Root Ganglion Stimulation, Stem Cell Therapy, Infusion Therapy

420 Deerwood RoadFort Lee, NJ 07024201-886-8877

HolyName.org/DrKBoard Certified in: Family MedicineHospital Affiliations: Holy Name Medical CenterSpecial Expertise: Geriatric Medicine, Obesity, Weight Loss, Wellness and Longevity

Long Island Plastic Surgical Group999 Franklin AveGarden City, NY 11530516-962-2271 www.lipsg.com Board Certified in: Plastic Surgery

Hospital Affiliations: Northwell Health, NYU Winthrop, Catholic Health ServicesSocieties: American Society for Aesthetic Plastic Surgery, Fellow, American College of Surgeons, American Society of Plastic SurgeonsSpecial Expertise: Eyelid and Facial Surgery, Post-Weight Loss Surgery, Breast Augmentation, Tummy Tuck, Hair Restoration, Facial Cosmetic Surgery

Long Island Plastic Surgical Group999 Franklin AveGarden City, NY 11530516-962-2271 www.lipsg.com

Hospital for Special Surgery541 East 71st Street 4th Floor New York, NY 10021 212-606-1585

www.hss.edu/physicians_qureshi- sheeraz.aspBoard Certified in: Orthopaedic SurgeryHospital Affiliation: Hospital for Special SurgerySpecial Expertise: Minimally Invasive Spine Surgery

Satjit Bhusri, MD, FACC Heidi A. Waldorf, MD H. Sasson, MD, FACS Sheeraz Qureshi, MD

Andrew Jacono, MD, FACS Robert A. Kayal, MD, FAAOS, FAAHKS

Corey W. Hunter, MD, FIPP Ohan Karatoprak MD

Samin K. Sharma MD, FACC, MSCAI

Laurence T. Glickman, MD, MSc, FRCS(C), FACS

The Blood & Marrow Transplant Group of Georgia

Leland M. Deane, MD, MBA, FACS

1305 York Ave 11th FloorNew York, NY 10128646-962-2020 vivo.med.cornell.edu/display/cwid-szk7001

weillcornell.org/skissBoard Certified in: OphthalmologyHospital Affiliations: Weill Cornell Medicine, New York-Presbyterian Hospital, Memorial Sloan Kettering Cancer CenterAppointments: Associate Dean, Clinical Compliance; Associate Professor, Ophthalmology; Chair, General Faculty Council; Chief, Retina Service; Vice Chair, Research; Vice Chair, Compliance; Director, Tele-Ophthalmology

Szilard Kiss, MD

11415 Tulane AveNew Orleans, LA 70112 504-988-5110

medicine.tulane.edu/departments/ surgery-medicine-endocrinology- metabolism-tulane-cancer-center/faculty emad-kandil-mdBoard Certified in: Surgery Hospital Affiliation: Tulane Medical CenterAppointments: Professor & Elias Hanna Chair in Surgery, Chief, General, Endocrine & Oncological Surgery Division, Member Tulane Cancer Center Executive committee Special Expertise: Thyroid and Parathyroid Surgery, RFA of thyroid nodules, robotic scarless surgery

Emad Kandil, MD, MBA, FACS, FACE

Dr. Jerry W. Chang, MD

www.MountSinai.orgBoard Certified in: Interventional Cardiology, Cardiovascular Disease and Internal MedicineHospital Affiliations: The Mount Sinai Hospital and Eternal Heart Care Centre, Jaipur, IndiaSpecial Expertise: Coronary Artery Disease, Interventional Cardiology and Valvular Intervention

Perimenopause, Menopause and Midlife Women’s Health1056 Fifth Ave Ste 1ANew York, NY 10028646-784-7252 www.DrAllmen.com Board Certified in: Gynecology

Societies: American College of Obstetrics & Gynecology, North American Menopause SocietySpecial Expertise: Perimenopause, Menopause, Bioidentical Hormone Therapy Host: Let’s Talk Menopause on PBSAuthor: Menopause Confidential

Tara Allmen, MD, FACOG

TARAALLMEN, MD

MenopauseConfidential

a doctor revealsthe secrets tothrivingthrough midlife

Board Certified in: Plastic SurgeryHospital Affiliations: NY Presbyterian-Queens, Northwell HealthSocieties: American Society of Plastic SurgeonsSpecial Expertise: Breast Reconstruction & Augmentation, Breast Reduction, Gynecomastia, Breast Revision, Liposuction & Abdominoplasty, Rhinoplasty, Eyelid Surgery/Blepharoplasty and Facial Rejuvenation

5670 Peachtree Dunwoody Road Suite 1000Atlanta, GA 30342404-255-1930 www.BMTGA.com

Northside Hospital AtlantaRecent Accolades: National Leaders in Allogeneic Blood and Marrow TransplantationSpecial Expertise: Acute Leukemia, Blood and Marrow Transplant, CAR T-Cell Immunotherapy and Clinical Research H. Kent Holland, MDAsad Bashey, MD, PhDMelhem Solh, MD

Scott Solomon, MDLarry Morris, MD

The Blood & Marrow Transplant Group of Georgia

9:30 AM Exhibitor Session

10:00 AM Welcome

Nicole Bell, LMSW, Vice President, Patient & Community Outreach The Leukemia & Lymphoma Society

Keynote Speaker

The Joy of Managing Your Survivorship Journey

Guadalupe Palos, DrPH, LMSW, RN, MD Anderson 10:45 AM Break/Exhibitor Session

11:00 AM Concurrent Morning Breakout Sessions

Myelodysplastic Syndromes (MDS)

Melhem Solh, MD, Northside Hospital Cancer Institute Blood & Marrow Transplant ProgramMyeloproliferative Neoplasms (MPN)

Vamsi Kota, MD, Georgia Cancer Center AugustaLymphoma High Grade

Mary Ninan, MD, Georgia Cancer Specialists affiliated with Northside HospitalChronic Lymphocytic Leukemia (CLL)

Sikander Ailawadhi, MD, Mayo Clinic FloridaSafe Movements: Medicine for the Mind, Body and Spirit

Wendy Baer, MD, Winship Cancer Institute of Emory UniversityNutrition in Survivorship: Eating to Support Health After Treatments

Nathan Schober, MS, RD, LD, CNSC, Cancer Treatment Centers of America 11:45 AM Break/Exhibitor Session

12:00 PM Concurrent Afternoon Breakout Sessions

Chronic Myeloid Leukemia (CML)

Jorge Cortes, MD, Georgia Cancer Center AugustaAdult Acute Leukemias (AML/ALL)

Martha Arellano, MD, Winship Cancer Institute of Emory UniversityWilliam D. Blum, MD, Winship Cancer Institute of Emory UniversityLymphoma Low Grade and Hodgkin Lymphoma

I. Brian Greenwell, MD, Hollings Cancer Center MUSCMultiple Myeloma

Brion Randolph, MD, Methodist University Hospital and University of Tennessee Health Science CenterSafe Movements: Medicine for the Mind, Body and Spirit

Wendy Baer, MD, Winship Cancer Institute of Emory UniversityNutrition in Survivorship: Eating to Support Health After Treatments

Nathan Schober, MS, RD, LD, CNSC, Cancer Treatment Centers of America 12:45 PM Evaluations and Conference Concludes

We look forward to having you at the VIRTUAL Georgia Blood Cancer Conference! We believe it is crucial to our mission to provide FREE education and information to all individuals diagnosed with a blood cancer and those who care for them. We appreciate your interest and look forward to having you attend the conference on September 26, 2020. Please note that while this virtual conference is free to attend, LLS pays for each participant to make this conference possible. Consequently, it is important to cancel your registration right away if you are unable to attend.

A Free VIRTUAL Educational Conference for Patients, Survivors, Caregivers and Healthcare Professionals

BLOOD CANCER CONFERENCEThis virtual Blood Cancer Conference (BCC) is one of many programs developed by The Leukemia & Lymphoma Society (LLS) to meet the needs of patients, survivors, families and oncology professionals, the people who deal with blood cancer every day and the people who care for them. BCC attendees receive the most current information and access to local resources to help navigate and make informed decisions about their treatment and survivorship.

REGISTRATION INFORMATIONThis is a free virtual conference for patients, survivors, families, caregivers and healthcare professionals* but REGISTRATION IS REQUIRED.

ONLINE: www.LLS.org/GABCC20

For general conference questions, grievances and requests for accommodations for those with disabilities, please contact Nina Logan, MD, Senior Manager, Patient & Community Outreach at:

EMAIL: Georgia.BCC@LLS.orgPHONE: 404.720.7838

*This is NOT a continuing education (CE) program.

SATURDAYSEPTEMBER 26, 20209:30AM – 12:45PM (ET)

IS GOING VIRTUALGEORGIA 2020

THANK YOU TO OUR PREMIER INTERNATIONAL PARTNER

THANK YOU TO OUR NATIONAL SPONSORS

THANK YOU TO OUR LOCAL SPONSOR

Dr. Melhem Solh Presented Current Updates in Myelodysplastic Syndromes (MDS) at the 2020 Virtual Blood Cancer Georgia Conference

9:30 AM Exhibitor Session

10:00 AM Welcome

Nicole Bell, LMSW, Vice President, Patient & Community Outreach The Leukemia & Lymphoma Society

Keynote Speaker

The Joy of Managing Your Survivorship Journey

Guadalupe Palos, DrPH, LMSW, RN, MD Anderson 10:45 AM Break/Exhibitor Session

11:00 AM Concurrent Morning Breakout Sessions

Myelodysplastic Syndromes (MDS)

Melhem Solh, MD, Northside Hospital Cancer Institute Blood & Marrow Transplant ProgramMyeloproliferative Neoplasms (MPN)

Vamsi Kota, MD, Georgia Cancer Center AugustaLymphoma High Grade

Mary Ninan, MD, Georgia Cancer Specialists affiliated with Northside HospitalChronic Lymphocytic Leukemia (CLL)

Sikander Ailawadhi, MD, Mayo Clinic FloridaSafe Movements: Medicine for the Mind, Body and Spirit

Wendy Baer, MD, Winship Cancer Institute of Emory UniversityNutrition in Survivorship: Eating to Support Health After Treatments

Nathan Schober, MS, RD, LD, CNSC, Cancer Treatment Centers of America 11:45 AM Break/Exhibitor Session

12:00 PM Concurrent Afternoon Breakout Sessions

Chronic Myeloid Leukemia (CML)

Jorge Cortes, MD, Georgia Cancer Center AugustaAdult Acute Leukemias (AML/ALL)

Martha Arellano, MD, Winship Cancer Institute of Emory UniversityWilliam D. Blum, MD, Winship Cancer Institute of Emory UniversityLymphoma Low Grade and Hodgkin Lymphoma

I. Brian Greenwell, MD, Hollings Cancer Center MUSCMultiple Myeloma

Brion Randolph, MD, Methodist University Hospital and University of Tennessee Health Science CenterSafe Movements: Medicine for the Mind, Body and Spirit

Wendy Baer, MD, Winship Cancer Institute of Emory UniversityNutrition in Survivorship: Eating to Support Health After Treatments

Nathan Schober, MS, RD, LD, CNSC, Cancer Treatment Centers of America 12:45 PM Evaluations and Conference Concludes

We look forward to having you at the VIRTUAL Georgia Blood Cancer Conference! We believe it is crucial to our mission to provide FREE education and information to all individuals diagnosed with a blood cancer and those who care for them. We appreciate your interest and look forward to having you attend the conference on September 26, 2020. Please note that while this virtual conference is free to attend, LLS pays for each participant to make this conference possible. Consequently, it is important to cancel your registration right away if you are unable to attend.

A Free VIRTUAL Educational Conference for Patients, Survivors, Caregivers and Healthcare Professionals

BLOOD CANCER CONFERENCEThis virtual Blood Cancer Conference (BCC) is one of many programs developed by The Leukemia & Lymphoma Society (LLS) to meet the needs of patients, survivors, families and oncology professionals, the people who deal with blood cancer every day and the people who care for them. BCC attendees receive the most current information and access to local resources to help navigate and make informed decisions about their treatment and survivorship.

REGISTRATION INFORMATIONThis is a free virtual conference for patients, survivors, families, caregivers and healthcare professionals* but REGISTRATION IS REQUIRED.

ONLINE: www.LLS.org/GABCC20

For general conference questions, grievances and requests for accommodations for those with disabilities, please contact Nina Logan, MD, Senior Manager, Patient & Community Outreach at:

EMAIL: Georgia.BCC@LLS.orgPHONE: 404.720.7838

*This is NOT a continuing education (CE) program.

SATURDAYSEPTEMBER 26, 20209:30AM – 12:45PM (ET)

IS GOING VIRTUALGEORGIA 2020

THANK YOU TO OUR PREMIER INTERNATIONAL PARTNER

THANK YOU TO OUR NATIONAL SPONSORS

THANK YOU TO OUR LOCAL SPONSOR

7FALL 2020/WINTER 2021 ISSUE |Northside Hospital Blood & Marrow Transplant Program

BMT/Leukemia ProtocolsDisease Trial

Number Name of Trial Drug & Link to clinicaltrials.gov

Leukemia, BMT and Supportive Care

AML NSH1169 A Phase I/II Study of SEL24 in Patients with Acute Myeloid Leukemia SEL124 NCT03008187

NSH1208 A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients with Hematologic Malignancies

Vyxeos NCT03555955

NSH1238 A Phase Ib Study of SEL120 in Patients with Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

SEL120 NCT04021368

NSH1260 A Phase I, Parallel, Open-Label Study of the Safety and Tolerability, Pharmacokinetics, and Antileukemic Activity of ASTX660 as a Single Agent and in Combination with ASTX727 in Subjects with Acute Myeloid Leukemia

ASTX727 NCT04155580

C374 A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy Versus Chemotherapy Alone in Patients with r/r AML

Uproleselan(GMI-1271) NCT03616470

Transplant

NSH1246 Phase II Trial Evaluating the Efficacy and Safety or Sargramostim Post Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Stem Cells with Post Transplant Cyclophosphamide

Sargamostim NCT04237623

AML NSH1150 Phase 2 Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High-Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation

Pembrolizumab NCT02771197

Aplastic Anemia NSH1158 A Study of T Cell Replete, HLA-Mismatched Bone Marrow Transplantation with Post-Transplant Cyclophosphamide as a Front-Line Therapy for Patients with Severe Aplastic Anemia Lacking HLA-Matched Related Donor

Fludarabine Cyclophos NCT02828592

Allogeneic Donors NSH1166 Infusion of CD34+ Selected Donor Hematopoietic Stem Cells/Bone Marrow Using the CliniMACS Humanitarian Use Device Protocol

NONE

Post Transplant

GVHD NSH1219 Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy with Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus Host Disease

Rituximab and Ibrutinib NCT04235036

C369 BMT CTN 1703 A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate Versus Post-Transplant Cyclophosphamide/ Tacrolimus/ Mycophenolate Mofetil in Non-Myeloablative/ Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

NCT03959241

C401 BMT CTN 1705 – A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha1-Antitrypsin (AAT) Combined with Corticosteroids Versus Corticosteroids Alone for the Treatment of High Risk Acute Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant

Alpha1-Antitrypsin (AAT) NCT04167514

Multiple Myeloma C389 Phase III Study of Daratumumab/rHuPh20 (NSC-810307) Plus Lenalidomide or Lenalidomide as Post Autologous Stem Cell Transplant Maintenance Therapy in Patient with Multiple Myeloma (MM) using Minimal Residual Disease to Direct Therapy Duration (Dramatic Study).

Daratumumab/rHuPh20 (NSC-810307) NCT04071457

NHL C282 Alliance A)51301-A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype.

NCT02443077

Supportive Care/Other

NSH721 NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository

NCT00495300 (sample) NCT01166009 (database)

NSH943 A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications

NCT01351545

NSH995 A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients

NCT01656603

C373 BMT CTN 1702 Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation

NCT03904134

C393 BMT CTN 1704 Composite Health Assessment Model for Older Adults: Applying Pre-Transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplantation (CHARM)

NCT03992352

8 | FALL 2020/WINTER 2021 ISSUE Transplant & Cellular Immunotherapy NEWS

Blood & Marrow Transplant Group at Northside Hospital

5670 Peachtree Dunwoody Road Suite 1000

Atlanta, GA 30342

To make a referral, or to speak with a physician, please call 404.255.1930.

(L-R) Drs. H. Kent Holland, Asad Bashey, Melhem Solh, Scott Solomon and Lawrence Morris

BMTGA Physicians

Effective January 1, 2021 BMTGA/Northside Hospital is an in-network AmbetterTM provider.