-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

2189 Graft-Versus-Host Disease after Anti-CD19 Chimeric Antigen Receptor T-Cell Infusion Post Allogeneic Hematopoietic Cell Transplantation: A Transplant Complications and Paediatric Disease Working Parties EBMT Joint Study

Program: Oral and Poster Abstracts
Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I
Hematology Disease Topics & Pathways:
Biological therapies, Research, Clinical Research, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Immunotherapy, Therapies, registries, survivorship, Transplantation
Saturday, December 9, 2023, 5:30 PM-7:30 PM

Guillermo Orti, MD, PhD1*, Christophe Peczynski, MSc2*, Christian Koenecke, MD3, William Boreland4*, Maeve O'Reilly5*, Martin Bornhäuser, MD6*, Adriana Balduzzi7, Caroline Besley, MD8*, Krzysztof Kalwak9*, Samppa Ryhanen Sr., MD, PhD10, Tayfun Güngör, MD11*, Robert F. Wynn, MRCP, MD, FRCPath12*, Peter Bader, MD, PhD13, Stephan Mielke, MD14, Didier Blaise, MD, PhD15, Persis Amrolia, FRCP, FRCPath, PhD16*, Ibrahim Yakoub-Agha, MD, PhD17*, Friso G. J. Calkoen, MD18, Maria-Luisa Schubert, MD19*, Victoria Potter20*, Wolfgang Holter, MD21*, Nicolaus Kröger, MD22*, Mi Kwon23, Henrik Sengeloev24*, Helene Schoemans, MD25*, Ivan Sergeevich Moiseev, MD26*, Olaf Penack, MD27* and Zinaida Peric, MD PhD28*

1Vall D' Hebron University Hospital, Barcelona, Spain
2EBMT Paris study office / CEREST-TC, Hôpital Saint Antoine, Sorbonne University, Paris, France
3Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, NDS, Germany
4EBMT Paris Study Unit, Paris, France
5Department of Haematology, University College London Hospitals, London, United Kingdom
6Department of Internal Medicine 1, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany
7Pediatric Hematopoietic Transplant Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy, School of Medicine and Surgery, Milano-Bicocca University, Milan, Italy
8Department of Haematology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom
9Department of Pediatric Hematology Oncology and BMT, Wroclaw Medical University, Wroclaw, Poland
10Hospital For Children and Adolescent, Helsinki University Central Hospital, Helsinki, FIN
11University Children's Hospital, Zürich, Switzerland, Zürich, Switzerland
12Royal Manchester Children's Hospital, Manchester, GBR
13Division for Stem Cell Transplantation and Immunology, University Children's Hospital Frankfurt, Frankfurt, Germany
14Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska Institute & University Hospital, Stockholm, Stockholms Laen, Sweden
15Program of Transplant and cellular immunotherapy, Department of Hematology, Institut Paoli Calmettes, Marseille, France
16Great Ormond Street Children’s Hospital, London, United Kingdom
17CHU de Lille, Université de Lille, INSERM U1286, Infinite, 59000, Lille, France
18Princess Maxima Center for Pediatric Oncology, Utrecht, Netherlands
19University of Heidelberg, Heidelberg, Heidelberg, DEU
20Department of Haematological Medicine, King's College Hospital NHS, London, United Kingdom
21St.Anna Children's Hospital, Vienna, Vienna, AUT
22University Hospital Eppendorf, Bone Marrow Transplantation Centre, Hamburg, Germany
23General University Hospital Gregorio Marañón, Madrid, Spain
24Rigshospitalet, Copenhagen, Denmark
25Department of Hematology,Department of Public Health and Primary Care, ACCENT VV, University Hospitals Leuven, KU Leuven - University of Leuven, Leuven, Belgium
26St Petersburg University, St Petersburg, Russian Federation
27Department of Hematology, Oncology, and Cancer Immunology, Charité Universitätsmedizin Berlin, Campus Virchow Klinik, Berlin, Germany
28University Hospital Center Rebro, Zagreb, Croatia


Anti-CD19 chimeric antigen receptor T-cells (CART) have been incorporated into the therapeutic landscape of B-acute lymphoblastic leukemia (B-ALL) and B-non-Hodgkin’s lymphoma (B-NHL). The manufacturing process of commercially available autologous CART in patients relapsing after allogeneic hematopoietic cell transplant (allo-HCT) might include T-cells of donor origin. In this setting, there is limited data on graft-versus-host disease (GvHD) as an off-target effect in patients treated with CART after allo-HCT. We hereby report on a large, retrospective, EBMT registry-based study on GvHD in patients treated with CART therapy after allo-HCT.


Inclusion criteria were B-ALL and B-NHL adult and pediatric allo-HCT patients, treated with a first anti-CD19 CART (axicabtagene ciloleucel [axi-cel] and tisagenlecleucel [tisa-cel]) from 2018 to August 2022. The primary study endpoints were the cumulative incidences (CI) of new acute GvHD (aGvHD) and chronic GvHD (cGvHD). Secondary endpoints were the 1-year GvHD relapse-free survival (GRFS), non-relapse mortality (NRM), and overall survival (OS). Overall data was analyzed in a descriptive manner.


A total of 257 allo-HCT patients treated with anti-CD19 CART were included. One hundred seventy-two patients (66.9%) were ≥18 years old. Tisa-cel was the therapy of choice in 184 patients (71.6%), whereas axi-cel was used in 73 patients (28.4%). More than half of the cohort (57.6%) underwent allo-HCT from unrelated donors. Notably, 109 patients (46.6%) and 38 patients (15%) had previously develop aGvHD and cGvHD between allo-HCT and CART infusion. Table 1 describes data on baseline patient, allo-HCT and CART characteristics of the whole cohort and of patients developing aGvHD and cGvHD.

In total, 3 patients developed new aGvHD and 6 patients developed new cGvHD after CART therapy. The 100-day CI of new aGvHD was 1.6% (95% CI, 0.4-4.2) and the 12-month CI of new cGvHD was 2.8% (95% CI, 1.1-5.7). No GvHD was observed in the pediatric cohort. The median time from allo-HCT to CART infusion was 15.8 months (range, 3.8-220.3) and the median times from CART to the development of aGvHD and cGvHD were respectively 44 days (range, 8-81) and 144 days (range, 5-182).

The 1-year GRFS and NRM were 52.1% (95% CI 45.6-59.4) and 4.7% (95% CI 2.5-8.1) respectively (Figure 1). With a median follow up of 18.8 months (95% CI, 16.2-23.7), the 1-year OS was 76.8% (95% CI 71.5-82.4). The most frequent cause of death was disease-related in 56 patients (74.6%).


Together, in this large cohort including adult and pediatric allo-HCT patients treated with tisa-cel and axi-cel after allo-HCT, these data show that the incidence of both aGvHD and cGvHD is very low. Of note, GvHD was not observed in the pediatric cohort. Furthermore, no excessive NRM was observed compared to previously published methods of treating relapse post allo-HCT, being disease progression a major hurdle to optimal outcomes in this cohort of patients.

Disclosures: Orti: JAZZ: Honoraria; Pfizer: Consultancy, Honoraria; Novartis: Honoraria; BMS: Honoraria; Incyte: Consultancy, Honoraria, Research Funding. Koenecke: Sanofi-Aventis: Consultancy, Speakers Bureau; Roche: Consultancy, Speakers Bureau; Kite/Gilead: Consultancy; Janssen: Consultancy, Speakers Bureau; Medigene: Consultancy; Amgen: Consultancy; Glaxo Smith Kline: Consultancy; Miltenyi Biotec: Consultancy; Novartis: Consultancy, Speakers Bureau; Pierre Fabre: Consultancy; BMS: Consultancy; Pfizer: Consultancy. O'Reilly: Kite-Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Conference support; Novartis: Honoraria, Other: Conference support; Janssen: Honoraria; Autolus: Membership on an entity's Board of Directors or advisory committees. Balduzzi: Neovii: Speakers Bureau; Medac: Speakers Bureau; Agmen: Speakers Bureau; Novartis: Speakers Bureau. Besley: Kite, Novartis, Janssen and Takeda: Honoraria. Wynn: Orchard Therapeutics: Patents & Royalties: Milestone payments MPSIIIA clinical trial, Research Funding; AVRO BIO: Consultancy, Patents & Royalties: Milestone payments MPSII clinical trial, Research Funding. Bader: Neovii: Research Funding; BMS: Research Funding; Novartis: Consultancy, Research Funding; Medac: Consultancy, Patents & Royalties: medac, Research Funding. Mielke: Immunicum/Mendes, Miltenyi: Other: Participation on a Data Safety Monitoring Board or Advisory Board; SWECARNET: Other: Founder/Leadership (via my institution) ; ScientifyResearch: Other: Founder (spouse) ; Celgene/BMS, Novartis, Janssen, Gilead/KITE, JSMO, Pfizer: Speakers Bureau. Amrolia: Autolus PLC: Patents & Royalties: via UCL Business. Yakoub-Agha: Janssen: Honoraria; Bristol-Myers Squibb: Honoraria; Novartis: Consultancy, Honoraria; Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel Support. Kröger: Neovii Biotech: Honoraria, Research Funding; MSD: Honoraria; Jazz: Honoraria; Kite/Gilead: Honoraria; Novartis: Honoraria, Research Funding; Pfizer: Honoraria; Riemser: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Takeda: Consultancy; Sanofi: Honoraria. Kwon: Jazz: Speakers Bureau; Pfizer: Speakers Bureau; Kite-Gilead: Consultancy, Speakers Bureau. Schoemans: Gilead: Other: Travel Support; Novartis: Honoraria, Research Funding; Janssen: Honoraria; Sanofi: Consultancy; Pfizer: Other: Travel Support. Penack: Gilead, Jazz, MSD, Novartis, Pfizer and Therakos: Honoraria, Other: Travel support; Incyte and Priothera: Research Funding; Equillium Bio, Jazz, Gilead, Novartis, MSD, Omeros, Priothera, Sanofi, Shionogi and SOBI: Membership on an entity's Board of Directors or advisory committees. Peric: Sanofi: Honoraria.

*signifies non-member of ASH