drugset / Trial / NCT04844866
Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-08-18
- Primary completion
- 2025-01-15
- Completion
- 2031-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Subject | MB-CART2019.1 | Cell therapy | 2.5e+06 cells/kg | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | Polatuzumab Vedotin | Other / unclassified | — | — |
| Comparator | Rituximab | Monoclonal antibody | — | — |