Prof. Dr. med. Marion Subklewe
Department of Medicine III at LMU Medical Center
Marion Subklewe is a professor of internal medicine at LMU Munich, a specialist in hematology and oncology, and the director of the Munich Center for Cell and Gene Therapy. She heads the Laboratory for Translational Cancer Immunology at the Genzentrum München as well as the CAR-T and immunotherapy program at LMU University Hospital Munich.
Her work combines basic research, clinical development, and patient care. As a principal investigator in over fifty Phase I through III trials and as the initiator of her own academic studies, she has personally overseen the development of novel cell therapies—from the target structure to their first use in humans—on multiple occasions. She is internationally recognized in two fields: the development of new cellular and antibody-based therapies for diseases for which there are currently no effective treatment options, particularly acute myeloid leukemia; and research into treatment-related toxicity, the findings of which have been incorporated into national and international guidelines. Clarivate lists her as a Highly Cited Researcher.
As director, she sees her role as that of an enabler: she brings together more than fifteen clinics and institutes into a single platform where every discipline at the site has access to the entire translational infrastructure.
Marion Subklewe is a professor of internal medicine at LMU Munich, a consultant hematologist and oncologist, and director of the Munich Center for Cell and Gene Therapy. She heads the Laboratory for Translational Cancer Immunology at the Gene Center Munich and the CAR-T and immunotherapy programs at LMU University Hospital.
Her work bridges basic research, clinical development, and patient care. As the principal investigator in more than fifty Phase I through III clinical trials and as the initiator of her own academic studies, she has repeatedly guided novel cell therapies from target discovery to their first application in humans. She is internationally recognized in two fields: the development of new cellular and antibody-based therapies for diseases that still lack effective treatment options—above all, acute myeloid leukemia—and research into therapy-associated toxicity, the findings of which have been incorporated into national and international guidelines. Clarivate lists her as a Highly Cited Researcher.
As Director, she sees her role as that of an enabler, bringing together more than fifteen clinics and institutes into a platform where every discipline on site has access to the full translational infrastructure
Prof. Marion Subklewe, M.D.
- Director of the Munich Center for Cell and Gene Therapy
- Consultant in the Department of Hematology/Oncology, Department of Medicine III, LMU Medical School, Munich
- Laboratory for Translational Cancer Immunology, Gene Center, LMU
Degree: Medical degree from the University of Aachen and the University of Cologne
Doctorate: Internal Medicine with a focus on Hematology/Oncology, University of Cologne
Board Certifications: Internal Medicine (2005), Hematology and Internal Oncology (2007)
2007: Habilitation in Internal Medicine, Charité, “Development of immunotherapeutic approaches for EBV-associated malignancies”
2014: W2 Professorship in Internal Medicine with a focus on Cellular Therapy, LMU Munich
- Member of the Walter Siegenthaler Society
- Member of the LMU-KUM Faculty Council (2023)
- Member of the Research Strategy Committee (“Forschungskommission”)
- Spokesperson for the LMU Munich site within the SFB-TR338 (TUM and Würzburg)
- Spokesperson for the Medical & Clinician-Scientist Program at the LMU Medical Faculty
- Founder and Spokesperson for "FAME" (Female Academia Medicine Excellence), a consortium of female professors at the LMU Medical Faculty
- Member of the DFG Expert Panel (Hematology/Oncology)
- Member of the Deutsche Krebshilfe section “Support for Young Medical and Scientific Professionals”
- Member of the Deutsche Krebshilfe CCC Network expert group “Immuno-Oncology”
- Member of the Scientific Advisory Board of the José Carreras Foundation
- Head of the “Molecular Oncology” module within the Elite Master’s Program in Human Biology—Principles in Health & Disease at the Faculties of Biology and Medicine, LMU
- Member of the steering committee of “GO-CART,” a joint consortium of the EHA and EBMT
- Member of the steering and organizing committee of the International Symposium “Acute Leukemias” and of iTOC (Immunotherapy of Cancer)
Collaborative research activities: German Consortium for Translational Cancer Research (DKTK); Bavarian Center for Cancer Research (BZKF); SFB-TR338 initiative “T cell engineering”; JÖSTER Foundation, CAR 360 degree, a collaborative project of LMU; Marie Skłodowska-Curie doctoral network “MIRACLE” (funded by the European Union’s Horizon Europe program); MetaboTargetAML project (funded by the European Partnership for Personalized Medicine, EP PerMed, under the European Union’s Horizon Europe program, grant agreement no. 101137129)
Grant reviews: German Research Foundation (DFG); German Cancer Aid; José Carreras Foundation; Wilhelm Sander Foundation; Cancer Research UK; Leukemia and Lymphoma; OeGHO; Dutch Cancer Society; Worldwide Cancer Research
Editorial work and manuscript reviews: Editor of EJC; Editor of *Blood Immunology and Cellular Therapy*; Editorial Board of *Blood*; reviewer for *Nature*, *Science*, *Cell*, *Leukemia*, *Lancet Hematology*, *NEJM*, *PLOS ONE*, *Journal of International Immunology*, *Journal of Hematology & Oncology*, *Haematologica*, *British Journal of Hematology*, *Journal of Immunotherapy*, *Oncoimmunology*, *Oncotarget*, *Blood Reviews*, *Blood Advances*
Memberships: Association of German Internists (BdI); European Hematology Association (EHA); American Society for Hematology (ASH); German Society for Hematology and Oncology (DGHO); Society for Immunotherapy of Cancer (SITC)
- Highly Cited Researcher 2024, 2025
- HemaSphere Award 2025, Top Cited Clinical Article
- EHA Educational Presentation 2021, 2022, 2023, 2025, 2026
- Pfleger Prize 2024
- ASH Educational (CART Tox) 2023
- ASH Educational (AML) 2023
- Grand Rounds at MD Anderson Cancer Center in 2018 and 2020, and at Moffitt Cancer Center in 2022
- ASH Abstract Achievement Awards 2011, 2016, 2018, 2020–2025
- M4 Award 2015: startup support for the development of novel multifunctional antibodies
- Therese of Bavaria Award 2012
- Best Lecturer at the Faculty of Medicine at LMU 2011
- Rahel Hirsch Scholarship 2005–2007 at the Charité
- Cure for Lymphoma Foundation Fellow, 1999–2000
- DFG Scholarship, 1996–1999
- Head of the Immunotherapy Program, LMU University Hospital Munich
- Head of the CAR T Program, LMU University Hospital Munich
- Head of the "iFLOW" Core Facility at the Medical Faculty of the University Hospital Munich
- Head of the Flow Cytometry & Sorting Unit within the Leukemia Diagnostics Lab (certified in 2011, accredited in 2012)
- Founder and Spokesperson for the national "Harmonize MRD Flow" Consortium
- Founder and Spokesperson for the harmonization of “CART Quantification” by the DGHO AK Labormedizin
- Member of the ELN Working Group on “MRD”
- Member of the Hematology Board Committee; Member of the Toxboard Immuno-oncology; Chair of the CART Board Committee
Principal Investigator in more than 50 oligo- and multicenter Phase I/II/III trials (CAR T, T-cell-recruiting antibodies, monoclonal antibodies, immunochemotherapy, small molecules) in leukemia, lymphoma, gastrointestinal tumors, multiple sclerosis, and other autoimmune diseases.
Investigator-initiated trials
- ERASE: Receptor-activated, in vitro-stimulated T cells for high-risk AML (BZKF)
- A Phase I first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CD33-targeted adapter-CAR T cells for the treatment of adult patients with relapsed/refractory (R/R) AML (BMBF)
- AARON Study: An open-label Phase II study of relatlimab (BMS-986016) with nivolumab (BMS-936558) in combination with 5-azacytidine for the treatment of patients with relapsed/refractory (R/R) AML and newly diagnosed AML
- DLI Target: Donor lymphocyte infusion plus blinatumomab
- New-generation dendritic cell vaccine for immunotherapy in AML (BayImmunet)
Further trials
- A phase 2, open-label, single-arm, multicohort, multicenter trial to evaluate the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (Transcend FL). Celgene Corporation; Phase II
- A global, randomized, multicenter, Phase 3 trial to compare the efficacy and safety of JCAR017 with the standard of care in adult patients with high-risk, transplant-eligible, relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (Transform). Celgene Corporation; Phase III
- A Phase 1/2 multicenter study evaluating the safety and efficacy of KTE-X19 in adult subjects with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL). Gilead; 2015-005009-35; Phase I/II
- A Phase I/II safety, dose-finding, and feasibility trial of MB-CART19.1 in patients with relapsed or refractory CD19-positive B-cell malignancies. Miltenyi Biotec GmbH; Phase I/II
- A Phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 427 in subjects with relapsed/refractory acute myeloid leukemia. Amgen; 2018-001389-40; Phase I
- A Phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 673 administered as short-term intravenous infusions in subjects with relapsed/refractory acute myeloid leukemia. Amgen Inc.; 2017-002980-16; Phase I
- A Phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 330 administered as a continuous intravenous infusion in subjects with relapsed/refractory acute myeloid leukemia. Amgen Inc.; 2014-004462-20; Phase I
- An open-label, multicenter, Phase 1b study of JNJ-74494550 (cusatuzumab; anti-CD70 monoclonal antibody) in combination with background therapy for the treatment of subjects with acute myeloid leukemia. Janssen; 2019-002808-41; Phase I
- A Phase 1, first-in-human, dose-escalation study of JNJ-67571244 (bispecific antibody targeting CD33 and CD3) in subjects with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Janssen-Cilag; 2018-004452-37; Phase I
- A Phase II trial for the treatment of older patients with newly diagnosed CD19-positive, Ph/BCR-ABL-negative B-precursor acute lymphoblastic leukemia using sequential dose-reduced chemotherapy and blinatumomab. University of Frankfurt am Main; 2017-002853-13; Phase II
- Optimization of therapy in adult patients with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) through individualized, targeted, and intensified therapy. University of Frankfurt am Main; 2013-003466-13; Phase III
- A multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia (Blast Successor Trial). University of Frankfurt am Main; 2015-000733-76; Phase II
- Midostaurin + gemtuzumab ozogamicin combination as first-line standard therapy for acute myeloid leukemia (MOSAIC). Technical University of Dresden; 2019-03863-23; Phase I/II
- A double-blind, placebo-controlled, randomized, multicenter Phase II study to assess the efficacy of adding BL-8040 to consolidation therapy in AML patients. Martin Luther University Halle-Wittenberg; 2014-002702-21; Phase II
- A Phase II randomized, open-label, multicenter study of the safety and efficacy of IMCgp100 compared with the investigator’s choice in HLA-A*0201-positive patients with previously untreated advanced uveal melanoma. Immunocore, Ltd.; 2015-003153-18; Phase II
- A Phase 3, multicenter, double-blind, randomized, placebo-controlled study of AG-120 in combination with azacitidine in subjects older than 18 years of age with previously untreated acute myeloid leukemia harboring an IDH1 mutation. Agios Pharmaceuticals; 2016-004907-30; Phase III
- A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia. Roche; 2020-001154-22; Phase III
- First-in-human study of MEN1112, a CD157-targeted monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia. Menarini Ricerche S.p.A.; 2014-002433-59; Phase I
- A Phase 3, multicenter, randomized, open-label study of guadecitabine (SGI-110) versus treatment of choice in adults with previously treated acute myeloid leukemia. Astex Pharmaceuticals; 2015-005256-97; Phase III