66th ASH Annual Meeting: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I

Symposia: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities Oral and Poster Abstracts
Poster

Research, Autoimmune disorders, Acute Myeloid Malignancies, AML, MDS, Clinical trials, Adult, Clinical Practice (Health Services and Quality), Lymphomas, Non-Hodgkin lymphoma, MPN, Translational Research, Elderly, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Plasma Cell Disorders, B Cell lymphoma, Clinical Research, T Cell lymphoma, Chronic Myeloid Malignancies, CMML, Pediatric, Diseases, Immune Disorders, Cell expansion, Patient-reported outcomes, Treatment Considerations, Biological therapies, Immunology, Immunotherapy, Aggressive lymphoma, Real-world evidence, Clinical procedures, Adverse Events, Lymphoid Malignancies, Young adult , Biological Processes, Myeloid Malignancies, Emerging technologies, Technology and Procedures, Study Population, Human, Measurable Residual Disease

Halls G-H (San Diego Convention Center)

2064

CD22-Directed CAR T-Cell Therapy Achieves Complete Remission in CD19-Directed CAR T-Cell Refractory Follicular and Mantle Cell Lymphoma

Anne Marijn Kramer, MD, PhD^1,2,3, Hrishikesh Srinagesh, MD, MSCR⁴^*, Yi-Jiun Su, MD^4,5^*, Mark P. Hamilton, MD, PhD^6,7, Kendall Levine⁸^*, Eleonora Migliore⁸^*, Kimi DeNoble⁸^*, Annie K. Brown, MS⁹^*, Kristen Cunanan, PhD¹⁰^*, Neha Agarwal, MS^2,4^*, Claire Lohman¹¹^*, Sharon Mavroukakis, MS¹²^*, Sushma Bharadwaj, MD¹³, Sally Arai, MD¹⁴, Laura Johnston, MD¹⁴, Robert Lowsky, MD¹⁴^*, Everett H. Meyer, MD, PhD¹⁵, Robert S. Negrin, MD¹⁴, Andrew R. Rezvani¹⁴^*, Judith Shizuru¹⁴^*, Lekha Mikkilineni, MD, MA¹⁶, Hitomi Hosoya, MD, PhD¹⁷, Parveen Shiraz¹⁴^*, Surbhi Sidana, MD¹⁸, Wen-Kai Weng, MD, PhD⁴, Vanessa E. Kennedy, MD¹⁶, Melody Smith, MD, MS¹⁸, Saurabh Dahiya, MD, FACP¹⁴^*, Kara L. Davis, DO¹⁹^*, Sneha Ramakrishna, MD²⁰^*, Liora Michal Schultz, MD²⁰, Ramya Tunuguntla, PhD²¹^*, Steven A. Feldman, PhD²^*, Lori Muffly, MD¹⁸, Crystal L. Mackall, MD¹², David B. Miklos, MD, PhD^6,16 and Matthew J. Frank^14,22

¹Cancer Center Amsterdam, Department of Hematology, Amsterdam UMC, Amsterdam, Netherlands
²Center for Cancer Cell Therapy, Stanford Cancer Institute, Stanford University, Stanford, CA
³Division of Blood and Marrow Transplantation & Cellular Therapy, Stanford University School of Medicine, Menlo Park, CA
⁴Division of Blood and Marrow Transplantation & Cellular Therapy, Stanford University School of Medicine, Palo Alto, CA
⁵Division of Hematology-Oncology, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan
⁶Stanford Cancer Institute, Center for Cancer Cell Therapy, Stanford University, Stanford, CA
⁷Department of Medicine, Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA
⁸Department of Bone Marrow Transplant and Cellular Therapy, Stanford University School of Medicine, Palo Alto, CA
⁹Laboratory of Cell and Gene Medicine, Stanford University School of Medicine, Palo Alto, CA
¹⁰Quantitative Sciences Unit, Stanford University School of Medicine, Palo Alto, CA
¹¹Cancer Correlative Science Unit, Stanford Cancer Institute, Palo Alto, CA
¹²Center for Cancer Cell Therapy, Stanford Cancer Institute, Stanford University School of Medicine, Stanford, CA
¹³Division of Blood and Marrow Transplantation and Cellular Therapy, Department of Medicine, Stanford University School of Medicine, Stanford, CA
¹⁴Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University, Stanford, CA
¹⁵Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University Medical Center, Stanford, CA
¹⁶Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Palo Alto, CA
¹⁷Division of Bone Marrow Transplant & Cellular Therapy,, Stanford University, Palo Alto, CA
¹⁸Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Stanford, CA
¹⁹Stanford University, Stanford, CA
²⁰Department of Pediatrics, Division of Hematology and Oncology, Stanford University School of Medicine, Palo Alto, CA
²¹Center for Cancer Cell Therapy, Stanford University, Stanford, CA
²²Stanford Cancer Institute, Center for Cancer Cell Therapy, Stanford University School of Medicine, Stanford, CA

2065

T-Lymphoblastic Lymphoma in a Patient with Pearson Syndrome Following Mitochondrial Augmentation

Elad Jacoby, MD¹, Reut Fluss, PhD¹^*, Efrat Glick Saar, PhD¹^*, Shachar Naor, MD¹^*, Ortal Barel, PhD¹^*, Niv Sabath²^*, Noa Sher, PhD²^*, Noa Greenberg-Kushnir, MD¹^*, Bella Bielorai, MD³^*, Natalie Yivgi Ohana, PhD²^*, Amos Toren⁴^* and Gideon Rechavi, MD, PhD¹^*

¹Sheba Medical Center, Ramat Gan, Israel
²Minovia Therapeutics, Tirat Carmel, Israel
³Sheba Medical Center, Ramat-Gan, Israel
⁴Sheba Medical Center, Tel-Hashomer, Israel

2066

Phase 1 Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients with CD7+ T-Cell Non-Hodgkin Lymphoma

Michael H. Kramer, MD, PhD¹, Neha Mehta-Shah, MD², Michael P. Rettig, PhD³, Katherine Stricker³^*, Melinda Harding³^*, Feng Gao⁴^*, Brett Ramsey, MBA⁵^*, Peter Westervelt, MD³, Jan K Davidson-Moncada, MD, PhD, MSc⁵, Armin Ghobadi, MD², John F. DiPersio, MD, PhD³ and Geoffrey L. Uy, MD⁶

¹Division of Oncology, Department of Medicine, Washington University School of Medicine, Saint Louis, MO
²Division of Oncology, Washington University School of Medicine, St. Louis, MO
³Division of Oncology, Washington University School of Medicine, Saint Louis, MO
⁴Department of Surgery, Division of Public Health Sciences, Washington University School of Medicine, Saint Louis, MO
⁵Wugen, Saint Louis, MO
⁶Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO

2067

A Phase 1 Dose Escalation and Expansion Trial of Third-Generation CD19-Directed CAR T-Cells Incorporating CD28 and Toll-like Receptor 2 (TLR2) Co-Stimulation for Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas (ENABLE-1)

Robert Weinkove, MBBS PhD^1,2^*, Philip George, MBBS^1,2^*, Robert Fyfe, MBChB^1,2^*, Aine Hurley, MBBChir^1,2^*, Nathaniel Dasyam, PhD¹^*, Yasmin Nouri, PhD^1,3^*, Tess Ostapowicz^1,4^*, Stefan Mullins, MB BCh^1,2^*, Giulia Giunti, PhD⁵^*, Brittany Lavender¹^*, Brigitta Mester, PhD¹^*, Catherine M. Bollard, MD⁶, Travis Perera, MBChB²^*, Hayden Jina, MBChB²^*, Alwyn D'Souza, MBChB²^*, Le Qin, PhD⁷^*, David S. Ritchie, MBChB PhD⁸, Chris M.A. Frampton, PhD⁹^*, Rachel Perret, PhD¹^*, Peng Li, PhD^7,10^* and Ian Hermans, PhD¹^*

¹Cancer Immunotherapy Programme, Malaghan Institute of Medical Research, Wellington, New Zealand
²Te Rerenga Ora Wellington Blood & Cancer Centre, Te Whatu Ora Health New Zealand Capital Coast & Hutt Valley, Wellington, New Zealand
³Division of Immunology, The Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia
⁴Clinical Trials Unit, Te Whatu Ora Health New Zealand Capital Coast & Hutt Valley, Wellington, New Zealand
⁵BioOra, Wellington, New Zealand
⁶Children's National Health System and The George Washington University, Washington, DC
⁷Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, Guangzhou, China
⁸Department of Medicine, The University of Melbourne, Melbourne, VIC, Australia
⁹Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand
¹⁰Wellington Zhaotai Therapies Limited, Wellington, New Zealand

2068

NKTR-255 Vs Placebo to Enhance Complete Responses and Durability Following CD19-Directed CAR-T Therapy in Patients with Relapsed/ Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Sairah Ahmed, MD¹, John F. DiPersio, MD, PhD², James H Essell, MD³, Catherine S. Diefenbach, MD⁴, Miguel Angel Perales, MD⁵, Cristina Castilla-Llorente, MD⁶^*, Saurabh Dahiya, MD⁷, Sohail Chaudhry, MD, PhD⁸^*, Heng Xu, PhD⁸^*, Yi Liu, PhD⁸^*, Christie Fanton, PhD⁸^*, Zachary Lee, PharmD⁸^*, Mario Q. Marcondes, MD, PhD⁹, Mary Tagliaferri, MD⁸^*, Jonathan Zalevsky, PhD⁸^*, David B. Miklos, MD, PhD⁷, Cameron J. Turtle, MBBS, PhD^10,11^* and Joseph P. McGuirk, DO¹²

¹Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
²Division of Oncology, Washington University School of Medicine, Saint Louis, MO
³Oncology/Hematology Care, Cincinnati, OH
⁴Perlmutter Cancer Center, NYU Langone Health, New York, NY
⁵Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
⁶Gustave Roussy Cancer Campus, Villejuif, France
⁷Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Palo Alto, CA
⁸Nektar Therapeutics, San Francisco, CA
⁹Nektar Therapeutics, Millbrae, CA
¹⁰Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA
¹¹University of Sydney, Sydney, NSW, Australia
¹²Division of Hematologic Malignancies & Cellular Therapeutics, University of Kansas Medical Center, Kansas City, KS

2069

BMS-986393, a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)-Targeted CAR T Cell Therapy, in Patients (pts) with Relapsed/Refractory (RR) Multiple Myeloma (MM) and 1–3 Prior Regimens: Updated Phase 1 Safety and Efficacy Results

Susan Bal, MD¹^*, Myo Htut, MD², Jesús G. Berdeja, MD³, Larry D Anderson Jr., MD, PhD⁴, Adriana Rossi, MD, MSc⁵, Tara Gregory, MD⁶, Thomas G. Martin, MD⁷, Luciano J. Costa, MD, PhD⁸, Hongxiang Hu, PhD⁹^*, Jinjie Chen, PhD⁹^*, Chaoqun Mei, PhD⁹^*, Naomey Sarkis, PharmD, RPh⁹^*, Alok Shrestha, MSc⁹^*, Safiyyah Ziyad, PhD⁹^*, Wei-Ming Kao, MD, PhD⁹^*, Allison J Kaeding, MD⁹^*, Michael R. Burgess, MD, PhD⁹ and Omar Nadeem, MD¹⁰

¹University of Alabama at Birmingham, Birmingham, AL
²City of Hope Comprehensive Cancer Center, Duarte, CA
³Sarah Cannon Cancer Center at Tennessee Oncology, Nashville, TN
⁴Hematologic Malignancies and Cellular Therapy Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX
⁵Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY
⁶Sarah Cannon Cancer Network, Colorado Blood Cancer Institute, Denver, CO
⁷University of California, San Francisco, San Francisco, CA
⁸Division of Hematology and Oncology, Department of Medicine, University of Alabama at Birmingham, Vestavia, AL
⁹Bristol Myers Squibb, Princeton, NJ
¹⁰Dana-Farber Cancer Institute, Boston, MA

2070

CD371-Targeted CAR T-Cells Secreting Interleukin-18 Exhibit Robust Expansion and Disease Clearance in Patients with Refractory Acute Myeloid Leukemia

Mark Blaine Geyer, MD^1,2, Susan DeWolf, MD³^*, Xiaoli Mi, MD¹, Brian C. Shaffer, MD, MS⁴, Briana Cadzin, RN⁵^*, Devin McAvoy⁶^*, Kinga K. Hosszu, PhD⁶^*, Kenyon Weis⁷^*, Rachel Lorenc⁸^*, Alexander M. Lewis⁷^*, Narina N. Girotra⁷^*, Erin R. Burns⁹^*, Jasmine S. Um⁹^*, Sarah Yoo⁹^*, Zoe Katsamakis⁶^*, Xiuyan Wang, PhD¹⁰^*, Isabelle Riviere¹¹^*, Kevin J. Curran, MD¹²^*, Jae H. Park, MD^3,13, Marcel R.M. van den Brink, MD, PhD¹⁴, Omar Abdel-Wahab, MD^2,7,8, Renier Brentjens, MD PhD¹⁵ and Anthony F. Daniyan, MD^1,3^*

¹Department of Medicine, Cell Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY
²Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
³Department of Medicine, Leukemia Service, Memorial Sloan Kettering Cancer Center, New York, NY
⁴Adult Bone Marrow Transplantation Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
⁵Department of Nursing, Memorial Sloan Kettering Cancer Center, New York, NY
⁶Department of Pediatrics, Immune Discovery and Modeling Service, Memorial Sloan Kettering Cancer Center, New York, NY
⁷Molecular Pharmacology Program, Sloan Kettering Institute, Memorial Sloan Kettering Cancer Center, New York, NY
⁸Weill Cornell Medical College, New York, NY
⁹Memorial Sloan Kettering Cancer Center, New York, NY
¹⁰Michael G. Harris Cell Therapy and Cell Engineering Facility, Memorial Sloan Kettering Cancer Center, New York, NY
¹¹Takeda Development Center Americas, Inc., Lexington, MA
¹²Department of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY
¹³Cell Therapy Service and Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY
¹⁴Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA
¹⁵Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY

2071

Non-Engrafting CD8-Depleted Human Leukocyte Antigen (HLA) Mismatched Unrelated Donor Lymphocyte Infusion (DLI) Achieves Remissions in Transplant-Naive Myelodysplastic Syndrome (MDS) and Secondary Acute Myeloid Leukemia (sAML)

Hany Elmariah, MD, MS¹, Jongphil Kim, PhD²^*, Kayla Reid, MS³^*, Christopher Cubitt, PhD⁴^*, Andrew T. Kuykendall, MD⁵, Jeffrey E Lancet, MD⁵, Rami S. Komrokji, MD⁵, David Sallman, MD⁵, Eric Padron, MD⁵, Onyee Chan, MD⁵, Kendra L. Sweet, MD⁵, Alison R. Walker, MD, MBA, MPH⁵, Albert J Ribickas⁴^*, Stephanie Dormesy⁶^*, Debra A Kessler⁶^*, Priscilla M Abedu⁶^*, Asmita Mishra, MD, MBA¹, Farhad Khimani, MD¹^*, Lia Perez, MD¹^*, Joseph A. Pidala, MD, PhD¹, Claudio Anasetti, MD¹^*, Ephraim Joseph Fuchs, MD, MBA⁷, Philip Imus, MD⁷, Michael D. Jain, MD, PhD¹, Frederick L. Locke, MD¹, Marco Davila, MD, PhD⁸, Nelli Bejanyan, MD¹ and Amy E. DeZern, MD⁷

¹Department of Blood and Marrow Transplantation and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL
²Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL
³Department of Clinical Science, Moffitt Cancer Center, Tampa, FL
⁴Moffitt Cancer Center, Tampa, FL
⁵Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL
⁶New York Blood Center, New York, NY
⁷Johns Hopkins University, Baltimore, MD
⁸Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY

2072

Autologous B Cell Maturation Antigen (BCMA) and CD19 Dual Targeting Fastcar-T Cells (GC012F/AZD0120) As First-Line Therapy for Elderly Patients with Newly Diagnosed Multiple Myeloma Patients

Juan Du, MD, PhD¹, Wanting Qiang¹^*, Jing Lu, MD¹^*, Yanchun Jia¹^*, Haiyan He¹^*, Jin Liu¹^*, Pei Guo¹^*, Ying Yang¹^*, Zhongyuan Feng¹^*, Lina Jin¹^*, Xiaoqiang Fan¹^*, Nina Shah, MD², Qi Zhang³^*, Jia Liu⁴^*, Lihong Weng³^*, Lianjun Shen³^* and Wei Cao³^*

¹Department of Hematology, Myeloma & Lymphoma Center, Shanghai Changzheng Hospital, Shanghai, China
²AstraZeneca, San Francisco, CA
³Gracell Biotechnologies Ltd., Shanghai, China
⁴Gracell Biotechnologies Ltd., Shanghai, FL, China

2073

CD19-Directed CAR T Cell Therapy in 4 Patients with Refractory Multiple Sclerosis

Johanna Richter¹^*, Felix Fischbach, M.D.²^*, Lena Kristina Pfeffer, M.D.²^*, Boris Fehse, PhD¹^*, Susanna Carolina Berger, M.D.¹^*, Stefanie Reinhardt²^*, Mathias Schäfersküpper¹^*, Franziska Elisabeth Marquard, M.D.¹^*, Kristin Rathje³^*, Nico Gagelmann, M.D.¹^*, Anita Badbaran, M. Sc.¹^*, Catherina Lück, M.D.¹^*, Dietlinde Janson, M.D.¹^*, Christine Wolschke, M.D.¹^*, Dominic Borie, M.D., Ph.D.⁴^*, Johann Seibel⁵^*, Francis A. Ayuk, M.D.¹^*, Manuel Friese, M.D.²^*, Christoph Heesen, MD²^* and Nicolaus Kroeger, M.D.¹

¹Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
²Institute of Neuroimmunology and Multiple Sclerosis and Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
³Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, AL, Germany
⁴Kyverna Therapeutics, Emeryville, CA
⁵Institute for Transfusion Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

2074

1‰ Regular Dose of Metabolically Armored CD19 CAR-T Cells Induces Robust In Vivo Expansion and Complete Remission in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients

Yongxian Hu, MD, PhD^1,2,3,4^*, Mingming Zhang^1,2,5,6^*, Shan Fu^2,5,7^*, Ruimin Hong^2,5,8^*, Jiazhen Cui^1,2,5,9^*, Simao Huang⁹^*, Min Gao, PhD¹⁰^*, Daojun Bai¹⁰^*, Jingjing Ren, PhD, MD¹⁰^*, Xingbing Wang¹¹^*, Yugang Guo, PhD^10,12^*, Li Tang, PhD¹³^* and He Huang, MD^2,4,14,15^*

¹Liangzhu Laboratory, Zhejiang University Medical Center, Hangzhou, China
²Institute of Hematology, Zhejiang University, Hangzhou, China
³Zhejiang Province Engineering Laboratory for Stem Cell and Immunity Therapy, Hangzhou, China
⁴Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
⁵Zhejiang Province Engineering Research Center for Stem Cell and Immunity Therapy, Hangzhou, China
⁶Bone Marrow Transplantation Center of The First Affiliated Hospital Liangzhu Laboratory, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
⁷Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China
⁸Bone Marrow Transplantation Center of The First Affiliated Hospital & Liangzhu Laboratory, Zhejiang University School of Medicine, Hangzhou, China
⁹Bone Marrow Transplantation Center of The First Affiliated Hospital Liangzhu Laboratory, Zhejiang University School of Medicine, Hangzhou, China
¹⁰Leman Biotech Co., Ltd., Shenzhen, China
¹¹The Flirst Affiliated Hospital Of University of Science and Technology of China, Hefei, Anhui, CHN
¹²Institute of Drug Metabolism and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University; State Key Laboratory of Advanced Drug Delivery and Release Systems, Zhejiang University, Hangzhou, China
¹³Institute of Materials Science & Engineering, École Polytechnique Fédérale de Lausanne, Lausanne, Switzerland
¹⁴Liangzhu Laboratory, Zhejiang University Medical Center, HangZhou, China
¹⁵Zhejiang Laboratory for Systems & Precision Medicine, Zhejiang University, Hangzhou, China

2075

CD7-Targeted CAR-T Cell Therapy Shows Promising Efficacy and Safety in Treating Refractory/Relapsed Peripheral T-Cell Lymphoma: Phase I Clinical Trial

Junfang Yang^1,2^*, Xian Zhang, MD^1,2^*, Jingjing Li^1,2^*, Liyuan Qiu²^*, Lin Wang³^* and Peihua Lu, MD^1,2

¹Beijing Lu Daopei Institute of Hematology, Beijing, China
²Hebei Yanda Lu Daopei Hospital, Langfang, China
³Hebei Senlang Biotechnology, Shijiazhuang, China

2076

CD123-CAR T Cells Manufactured in the Presence of Dasatinib Induce High Grade CRS and/or IEC-HS without Improving Efficacy in Pediatric Patients with Recurrent/Refractory Leukemia

Swati Naik, MBBS¹, Madden Renee, MD²^*, Aimee C. Talleur, MD², Rebecca Epperly, MD², Timothy Lockey, PhD³^*, Jennyfer Bran, MD⁴^*, Liqing Tian⁵^*, Ying Li⁶^*, Dinesh Keerthi²^*, Alexandra Boyd⁷^*, Amanda Lipsitt⁴^*, Jeffrey E. Rubnitz, MD, PhD⁸, Jeffery M Klco, MD, PhD⁹, Barry Shulkin, MD¹⁰^*, Sarah Schell⁵^*, Polly Adams⁷^*, Jeoungeun John Park⁴^*, Janice Riberdy, PhD¹¹^*, Na Shang⁴^*, Jaquelyn T. Zoine, PhD⁵, Raghuvaran Shanmugam¹²^*, Chris Nevitt, PhD²^*, Unmesha Thanekar⁷^*, Jennifer Wallace⁴^*, Elaine Harstead⁴^*, Scott Perry⁷^*, Catherine Willis⁵^*, Jean-Yves Metais, Ph.D.²^*, Deanna M. Langfitt, PhD¹³^*, Sheng Zhou, PhD¹⁴, Salem M. Akel, PhD¹⁵^*, Caitlin Zebley, MD, PhD⁶^*, Jeremy Chase Crawford, PhD¹²^*, Benjamin Youngblood, PhD¹⁶^*, Paul G. Thomas, PhD¹²^*, Frank Fazio⁵^*, Brandon M Triplett, MD²^*, Stephen Gottschalk, MD² and Mireya Paulina Velasquez, MD²

¹Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Research Hospital, Memphis, TX
²Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Research Hospital, Memphis, TN
³Department of Therapeutics Production and Quality, St. Jude Children's Research Hospital, Memphis, TN
⁴ST. JUDE CHILDREN'S RESEARCH HOSPITAL, Memphis, TX
⁵St. Jude Children's Research Hospital, Memphis, TN
⁶Department of Bone Marrow Transplantation and Cellular Therapy, St Jude Children's Research Hospital, Memphis, TN
⁷St Jude Children's Research Hospital, Memphis, TN
⁸Department of Oncology, St. Jude Children's Research Hospital, Memphis, TN
⁹Department of Pathology, St. Jude Children's Research Hospital, Memphis, TN
¹⁰Department of Diagnostic Imaging, St. Jude Children's Research Hospital, University of Tennessee Health Science Center, Memphis, TN
¹¹Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Research Hospital, Memphis, TN
¹²Department of Host Microbe Interactions, St. Jude Children's Research Hospital, Memphis, TN
¹³Department of Bone Marrow Transplant and Cellular Therapy, St. Jude Children's Research Hospital, Memphis, TN
¹⁴Experimental Cellular Therapeutics Laboratory, St. Jude Children's Research Hospital, Memphis, TN
¹⁵St. Jude Children’s Research Hospital, Memphis, TN
¹⁶St Jude Children's Research Hospital, Memphis

2077

Secondary Hematologic Malignancies in Patients Following Chimeric Antigen Receptor T-Cell Therapy: Aggregated Clinical Trial Data from 1542 Patients

Edward R Scheffer Cliff, MBBS, MPH¹, Penelope Lafeuille²^*, Sheila Diamond, MS, CGC²^*, Jacob Aptekar, MD, PhD²^*, David A Russler-Germain, MD, PhD³, Kai Rejeski, MD⁴ and Aaron S Kesselheim, MD, JD, MPH⁵^*

¹Peter MacCallum Cancer Centre, Parkville, Australia
²Medidata AI, Medidata, a Dassault Systemes Company, New York, NY
³Siteman Cancer Center, Division of Oncology, Washington University School of Medicine, Saint Louis, MO
⁴Department of Medicine III, LMU University Hospital, Munich, Germany
⁵Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA

2078

Initial Results of a First-in-Human, Phase I Study Point-of-Care Manufacturing of Trispecific CAR-T Cells Targeting CD19/20/22 in B-Cell Malignancies

Sumithira Vasu, MD, MBBS¹, Evandro Bezerra, MD², Nathan Denlinger, DO, MS², Nicole Szuminski¹^*, Dina Schneider, PhD³, Pradyot Dash, PhD⁴, Louisa Wirthlin⁵^*, Narendranath Epperla, MD, MS⁶, Yazeed Sawalha, MD², Jennifer A. Woyach, MD⁷, Kerry A. Rogers, MD², Seema A Bhat, MD², Gregory K Behbehani, MD, PhD⁸, Karilyn T. Larkin, MD⁸, Adam S Kittai, MD⁹, Wing Chan, PhD¹⁰, Ashley Angell Krull¹¹^*, Shamama Nishat, PhD¹^*, Lynn O'Donnell, PhD¹^*, Lapo Alinari, MD, Ph.D¹⁰ and Marcos de Lima, MD¹²

¹The Ohio State University, Columbus, OH
²Division of Hematology, The Ohio State University, Columbus, OH
³Lentigen, Gaithersburg, MD
⁴Lentigen, a Miltenyi Biotec Company, Gaithersburg, MD
⁵Miltenyi Biotec, Gaithersburg, MD
⁶Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus, OH
⁷Division of Hematology, Ohio State University Comprehensive Cancer Center, Columbus, OH
⁸Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH
⁹Icahn School of Medicine at Mount Sinai, New York, NY
¹⁰James Comprehensive Cancer Center, The Ohio State University, Columbus, OH
¹¹The Ohio State University Wexner Medical Center, Columbus, OH
¹²Department of Internal Medicine, Division of Hematology, The Ohio State University - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH

2079

Myeloid Neoplasia after CD19 Directed CAR-T Cells : Cumulative Incidence, Risk Factors and Outcome

Nicolas Gazeau¹^*, David Beauvais, MD²^*, Rémi Tilmont¹^*, Micha Srour³^*, Emmanuelle Ferrant^4,5,6^*, Violaine Safar, MD⁷^*, Gandhi Damaj, MD, PhD^8,9^*, Nicolas Gower¹⁰^*, Nicolas Duployez, PharmD, PhD¹¹^*, Sarah Huet¹²^*, Herve Ghesquieres, MD, PhD¹³^*, Emmanuel Bachy, MD, PhD¹⁴, Franck Morschhauser, MD, PhD¹, Ibrahim Yakoub-Agha, MD, PhD¹⁵^*, Mael Heiblig¹⁶^* and Pierre Sesques, MD¹⁷^*

¹Centre Hospitalier Universitaire de Lille, Lille, France
²Hematology Department., CHRU Lille, Lille, FRA
³CHU de Lille, Lille, France
⁴Department of Hematology, Lyon Sud Hospital, Pierre Benite, France
⁵Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie Clinique, Pierre-Bénite, France
⁶CHU Lyon Sud, Pierre Benite, FRA
⁷Department of hematology, Lyon Sud university hospital, HCL, Lyon, France
⁸CHU Caen, Caen, Normandy, FRA
⁹Hematology Institute, University Of Caen Normandie Hospital Center, Caen, France
¹⁰Clinical Hematology, Lille University Hospital, Lille, France
¹¹Laboratory of Hematology-Molecular Biology, Centre Hospitalier Universitaire (CHU) de Lille, Lille, France
¹²Laboratory of Haematology, CHU Lyon-Sud, Hospices Civils de Lyon, Pierre-Benite, Lyon, France
¹³Hematology Department, Centre Hospitalier Lyon Sud, Pierre-Bénite, France
¹⁴Lyon Sud Hospital, Lyon, France
¹⁵CHU de Lille, Univ Lille, INSERM U1286, Infinite, 59000, LILLE, France
¹⁶Hematology Department, Hospices Civils de Lyon, Pierre Bénite, Lyon, France, LYON, FRA
¹⁷CHU Lyon-Sud, Hospices Civils de Lyon, Lyon, France

2080

Safety and Tolerability of BCMA-Directed mRNA CAR T-Cell Therapy in Multiple Myeloma and Autoimmune Disease

Milos D Miljkovic, MD, MSc¹, Adam S. Asch, MD²^*, Gregory Orloff, MD³^*, Ralph Boccia, MD⁴^*, Jesús G Berdeja, MD⁵, Fevzi Altuntas, MD⁶^*, Stefan O. Ciurea, MD⁷, James F Howard Jr., MD⁸^*, Tuan Vu, MD⁹^*, Bennett Myers, MD¹⁰^*, Nizar Chahin, MD¹¹^*, Tahseen Mozaffar, MD¹²^*, Christopher M Jewell, PhD¹³^* and Metin Kurtoglu, MD, PhD¹³^*

¹Cartesian Therapeutics, Frederick, MD
²Oklahoma University/Stephenson Cancer Center, Oklahoma City, OK
³Virginia Cancer Specialists, Fairfax, VA
⁴Center for Cancer and Blood Disorders, Johns Hopkins Medicine, Bethesda, MD
⁵Sarah Cannon Center For Blood Cancers, Nashville, TN
⁶Ankara Oncology Training and Research Hospital, Yenimahalle/Ankara, Ankara, Turkey
⁷Hematopoietic Stem Cell Transplantation and Cellular Therapy Program, Division of Hematology/Oncology, Department of Medicine, University of California Irvine, Orange, CA
⁸Department of Neurology, University of North Carolina Chapel Hill, Chapel Hill, NC
⁹Department of Neurology, University of South Florida, Tampa, FL
¹⁰DENT Neurologic Institute, Buffalo, NY
¹¹Department of Neurology, Oregon Health and Sciences University, Portland, OR
¹²Department of Neurology, University of California Irvine, Irvine, CA
¹³Cartesian Therapeutics, Gaithersburg, MD

2081

Pre-CAR-T GTE Scoring of Electroencephalogram Abnormalities As Predictive Biomarkers for Icans

Hidetaka Nakagaki, MD¹^*, Takuji Yamauchi, MD, PhD²^*, Takahiko Mukaino³^*, Ayumi Sakata⁴^*, Eriko Watanabe⁵^*, Mitsuru Watanabe³^*, Daisuke Ishihara⁶^*, Hiroshi Imanaga, MD⁷^*, Kensuke Sasaki, MD, PhD⁷^*, Teppei Sakoda⁶^*, Fumiaki Jinnouchi⁸^*, Kohta Miyawaki⁸^*, Takahiro Shima, MD, PhD⁹, Yoshikane Kikushige¹⁰^*, Yasuo Mori, M.D., Ph.D.¹¹^*, Yuya Kunisaki⁶^*, Taeko Hotta¹²^*, Hiroshi Shigeto¹³^*, Noriko Isobe³^*, Koichi Akashi, MD, PhD²^* and Koji Kato, MD, PhD⁷

¹Department of Hematology, Oncology & Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan
²Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan
³Department of Neurology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JPN
⁴Department of Clinical Chemistry and Laboratory Medicine, Kyushu University Hosp, Fukuoka, JPN
⁵Department of Clinical Chemistry and Laboratory Medicine, Kyushu University Hosp, Fukuoka, Japan
⁶Kyushu University Graduate School of Medical Sciences, Fukuoka, JPN
⁷Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan
⁸Kyushu University, Fukuoka, JPN
⁹Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medicine, Fukuoka, Japan
¹⁰Center for Cellular and Molecular Medicine, Fukuoka, JPN
¹¹Hematology, Oncology & Cardiovascular medicine, Kyushu University Hospital, Fukuoka, JPN
¹²Kyushu University Hospital, Fukuoka, JPN
¹³Division of Medical Technology, Department of Health Sciences, Graduate School O, Fukuoka, JPN

2082

Efficacy and Safety of CAR-T Therapy Targeting CLL1 in Patients with Extramedullary Diseases of Acute Myeloid Leukemia

Yifan Zhao¹^*, Xue Bai¹^*, Shujing Guo¹^*, Xiaomei Zhang²^* and Mingfeng Zhao^2,3

¹Tianjin First Central Hospital, Tianjin, China
²Medical School of Nankai University, Tianjin, China
³Department of Hematology, Tianjin First Central Hospital, School of Medicine, Nankai University, Tianjin, China

2083

Late Polyclonal P-BCMA-101 CAR-T Cell Re-Expansion and Rapid Complete Response in a Patient with Relapsed Multiple Myeloma Treated with One Cycle of Talquetamab, More Than 3 Years after CAR-T Infusion

Anupama Deepa Kumar, MD¹, Ajai Chari, MD¹, Srishti Gupta²^*, Joseph Rohr, MD, PhD³^*, Rajesh Belani, MD⁴^*, Blair Madison, PhD⁴^*, Zhibo Ma, PhD⁴^*, Chris E Martin, PhD⁴^*, Katherine McArthur⁵^*, Hilary Ostwald⁶^*, Syed Rizvi, MD⁷ and Thomas G. Martin, MD⁸

¹University of California, San Francisco, San Francisco, CA
²University of California San Francisco, San Francisco, CA
³UCSF, San Francisco, CA
⁴Poseida Therapeutics, San Diego, CA
⁵Poseida Therapeutics, San Deigo, CA
⁶Poseida Therapeutics, Inc., San Diego, CA
⁷Poseida Therapeutics, Inc., San Diego
⁸Department of Hematology, University of California at San Francisco, San Francisco, CA

2084

The CAR-Hematotox Identifies Patients at High Risk of Infectious/Inflammatory Complications in a Cohort of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Treated with ARI-0001 (Varnimcabtagene Autoleucel)

Maria Isabel Arbelaez Monroy, MD¹^*, Nil Albiol, MD²^*, Alexandra Martínez-Roca^2,3^*, Nuria Martínez-Cibrián, MD⁴^*, Cristina Arnaldos⁵^*, Marta Español-Rego⁶^*, Sergio Navarro-Velazquez⁷^*, Helena Brillembourg¹^*, Beatriz Merchan¹^*, Leticia Alserawan⁸^*, Maria Castella⁷^*, Daniel Benitez-Ribas⁹^*, Mercedes Montoro-Lorite¹⁰^*, Pilar Ayora²^*, Carla Ramos⁴^*, Carlos Fernández de Larrea, MD¹¹, E. Azucena González-Navarro¹^*, Alvaro Urbano-Ispizua, MD, PhD¹, Jordi Esteve Reyner¹, Manel Juan¹²^*, Julio Delgado, MD, PhD¹^*, Luis Gerardo Rodríguez-Lobato¹³^* and Valentin Ortiz-Maldonado, MD¹⁴

¹Hematology Department, Hospital Clínic de Barcelona, Barcelona, Spain., Barcelona, Spain
²Hematology Department, Hematology Department, Hospital Clínic Barcelona, Barcelona, Spain, Barcelona, Spain
³Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS), Barcelona, Spain
⁴Hematology Department, Hospital Clínic Barcelona, Barcelona, Spain, Barcelona, Spain
⁵Immunology Department, Hospital Clínic de Barcelona, Barcelona, Spain., Barcelona, Barcelona, Spain
⁶Immunology Department, Hospital Clínic de Barcelona, Barcelona, Spain., Barcelona, Spain
⁷Immunology Department, Hospital Clínic de Barcelona, Barcelona, Spain., Barcleona, Spain
⁸Hospital Clínic de Barcelona, Barcelona, Spain
⁹Department of Immunology, Hospital Clínic de Barcelona, Barcelona, Spain., Barcelona, ESP
¹⁰Hematology Department, Hospital Clínic de Barcelona, Barcelona, Spain., Barcelona, ESP
¹¹Hosp. Clinic I Provincial de Barcelona, Barcelona, Spain
¹²Immunology Department, Hospital Clínic de Barcelona, Barcelona, Spain, Plataform of Immunotherapy Clínic-Sant Joan de Déu, Barcelona; Spain, Barcelona, ESP
¹³Department of Hematology, Hospital Clínic de Barcelona, Barcelona, Spain., Barcelona, Spain
¹⁴Hematology Department, Hematology Department, Hospital Clínic Barcelona, Barcelona, Spain, Barcelona, ESP

2085

A Phase I Study of CD19 CAR T-Cells with Escalating Doses of Lymphodepletion with or without Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Naseem S. Esteghamat, MD^1,2, Joseph M Tuscano, MD¹, Brian A. Jonas, MD, PhD³, Aaron S. Rosenberg, MD⁴, Rasmus T. Hoeg, MD⁵^*, Francisco Andres Socola, MD¹, Brian Fury⁶^*, Jordan Pavlic, MA⁷^*, Geralyn Annett⁸^*, Jan A. Nolta, PhD⁹^* and Mehrdad Abedi, MD¹⁰^*

¹Department of Internal Medicine, Division of Malignant Hematology/Cellular Therapy and Transplantation, University of California, Davis Medical Center Comprehensive Cancer Center, Sacramento, CA
²UC Davis Comprehensive Cancer Center, Sacramento
³UC Davis Comprehensive Cancer Center, Davis, CA
⁴UC Davis Comprehensive Cancer Center, Sacramento, CA
⁵Comprehensive Cancer Center, University of California, Davis, Sacramento, CA
⁶UC Davis GMP Facility, Sacramento
⁷University of California, Davis Graduate Group in Immunology, GMP Facility, Sacramento, CA
⁸Department of Internal Medicine, University of California, Davis, Sacramento, CA
⁹University of California, Davis, Sacramento, CA
¹⁰University of California Davis, Sacramento, CA

2086

Standardization Protocol to Mitigate Progression of Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS) in Elderly Patients Treated with CD28 Co-Stimulatory Anti-CD19 CAR-T Cells – a Pilot Study

Gil Fridberg, MD^1,2,3,4^*, Odelia Amit, MD³^*, Mohamad Ganayem, MD⁵^*, Felix Bukstein, MD^6,7^*, Chava Perry, MD^3,7^*, Irit Avivi Mazza^3,7,8,9,10^*, Ronit Gold, RN¹¹^* and Ron Ram, MD^7,12,13,14

¹Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel, Tel Aviv, Israel
²Hematology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
³BMT Unit, Tel Aviv Sourasky Medical Center and Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
⁴Department of Hematology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
⁵BMT Unit Tel Aviv Sourasky Medical Center, Tel Aviv, ISR
⁶Neuro Oncology Unit Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
⁷Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
⁸Tel Aviv Sourasky Medical Center and Tel Aviv University, Tel Aviv, Israel
⁹Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
¹⁰Hematology Division, Sourasky Medical Center and the Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
¹¹Tel Aviv Medical Center, Tel Aviv, ISR
¹²Department of Hematology, Tel Aviv medical center, Tel Aviv, Israel
¹³BMT Unit, Tel Aviv (Sourasky) Medical Center, Tel Aviv, Israel
¹⁴Bone Marrow Transplant Unit, Tel Aviv (Sourasky) Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

2087

Long-Term Efficacy and Safety of CD19-Specific CAR-T Cells Armed with IL-7 and CCL19 in Patients with Relapsed or Refractory Large B-Cell Lymphoma: A Multi-Center Prospective Study

Wenbin Qian¹, Hui Liu, MD, PhD²^*, Wen Lei^2,3^*, Linqin Wang⁴^* and Panpan Chen⁵^*

¹Department of Hematology,The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
²Department of Hematology, The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
³The Second Affiliated Hospital, College of Medicine, Zhejiang University, Department of Hematology, China, Hangzhou, China
⁴Bone Marrow Transplantation Center of The First Affiliated Hospital & Liangzhu Laboratory, Zhejiang University School of Medicine, Hangzhou, China
⁵Department of Hematology,The Second Affiliated Hospital, College of Medicine, Zhejiang University,Hangzhou, China, Hangzhou, China

2088

Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy Manufactured Using a Next-Generation Process, for Severe, Refractory Autoimmune Diseases: Updated Data from Ongoing Phase 1, Multicenter, Open-Label Studies

Fabian Mueller, MD¹, Krish Patel, MD²^*, Ran Reshef, MD, MSc³, Mohamad Cherry, MD, MSc⁴, Richard Nash, MD⁵^*, Ernesto Ayala, MD⁶, Jingmei Hsu, MD, PhD⁷, Jacques Azzi⁸^*, Peter Vandenberghe, MD, PhD⁹, Roch Houot, MD, PhD¹⁰^*, Bastian von Tresckow¹¹, Giuseppina Stifano¹²^*, Ashley Koegel, MD¹³, Susana Falcon¹³^*, Burhan Chaudhry¹³^*, Lisa Kelly¹³^*, Jerill Thorpe¹⁴^*, Alyse Frisbee¹⁴^*, Sam Charab¹⁴^*, Sharmila Das¹³^*, Thomas Ly¹⁵^*, Ken Ogasawara, PhD, MPH¹³^* and Paolo Caimi¹⁶^*

¹Department of Internal Medicine 5, Hematology and Oncology, University Hospital Erlangen, Erlangen, Germany
²Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute, Seattle, WA
³Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, NY
⁴Atlantic Health System, Morristown, NJ
⁵Health One Cares, Denver, CO
⁶Department of Hematology/Oncology, Mayo Clinic, Jacksonville, FL
⁷NYU Perlmutter Cancer Center, NYU Grossman School of Medicine, New York, NY
⁸Icahn School of Medicine at Mount Sinai, New York, NY
⁹University Hospitals Leuven, Leuven, Belgium
¹⁰University Hospital CHU de Rennes, Rennes, France
¹¹Department of Hematology and Stem Cell Transplantation, West German Cancer Center and German Cancer consortium (DKTK partner site Essen), University Hospital Essen, University of Duisburg-Essen, Essen, Germany
¹²Bristol Myers Squibb, Cambridge, MA
¹³Bristol Myers Squibb, Princeton, NJ
¹⁴Bristol Myers Squibb, Seattle, WA
¹⁵Bristol Myers Squibb, San Diego, CA
¹⁶Cleveland Clinic Taussig Cancer Institute, Cleveland, OH

2088.1

NK Cell Immunotherapy to Reduce Relapse after Haploidentical Transplant for High-Risk Pediatric and Young Adult AML

Thomas Pfeiffer¹^*, Stephanie Hyde¹^*, Amanda F. Cashen, MD², Jeffrey J. Bednarski, MD, PhD¹ and Todd A Fehniger³

¹Department of Pediatrics, Division of Hematology / Oncology, Washington University School of Medicine, Saint Louis, MO
²Washington University School of Medicine, Saint Louis, MO
³Department of Medicine, Division of Oncology, Washington University School of Medicine, Saint Louis, MO

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^*signifies non-member of ASH

704.P1.77 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster I