Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
Recruiting now · Phase 2
Conditions studied: Diffuse Large B-cell Lymphoma
In brief
In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. Part II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.
Key facts
- Study ID
- NCT04844866
- Run by
- Miltenyi Biomedicine GmbH
- People needed
- 213
- Starts
- 2021-08-18
- Expected to finish
- 2031-09-30
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Universitaetsklinikum Heidelberg — Heidelberg, Germany (enrolling)
- Klinikum der Universitat München, Studienzentrale fur Hematologie der Medizinischen Klinik II — München, Germany (enrolling)
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
- Universitatsklinikum Innsbruck Universitatsklinik fur Innere Medizin V — Innsbruck, Austria (enrolling)
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg — Leuven, Belgium (enrolling)
- Universitätsklinikum Leipzig — Leipzig, Germany (enrolling)
- Universitaetsklinikum Essen — Essen, Germany (enrolling)
- FNsP Ostrava — Ostrava, Czechia (enrolling)
- Jules Bordet lnstitute — Anderlecht, Belgium (enrolling)
- Oulu University Central Hospital — Oulu, Finland (enrolling)
- Turku University Hospital — Turku, Finland (enrolling)
- Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor — Créteil, France (enrolling)
- University Hospital Center Zagreb — Zagreb, Croatia (enrolling)
- Ordensklinikum Linz GmbH Elisabethinen — Linz, Austria (enrolling)
- University Hospital Hradec Kralove — Hradec Králové, Czechia (enrolling)
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) — Vienna, Austria (enrolling)
- Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque — Pessac, France (enrolling)
- Centre Hospitalier Universitaire de Poitiers — Poitiers, France (enrolling)
- Institut Universitaire du Cancer Service d´hématologie — Toulouse, France (enrolling)
- CHU de Nancy Hopitaux de Brabois — Vandœuvre-lès-Nancy, France (enrolling)
- Universitatsklinikum Augsburg — Augsburg, Germany (enrolling)
- Universitaetsklinikum Knappschaftskrankenhaus Bochum der Ruhr-Universitat Bochum — Bochum, Germany (enrolling)
- Universitaetsklinikum Koeln — Cologne, Germany (enrolling)
- Klinikum Erlangen der Friedrich-Alexander-Universitaet Erlangen-Nuernberg — Erlangen, Germany (enrolling)
- University Hospital Regensburg — Regensburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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