drugset / Trial / NCT03853616
MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase l multi-centric, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. In total approximately 48 patients will be included in the trial. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
Timeline
- Start
- 2018-11-26
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CD19 CAR-T cells | Cell therapy | 100000 cells | — |
| Subject | anti-CD19 CAR-T cells | Cell therapy | 500000 cells | — |
| Subject | anti-CD19 CAR-T cells | Cell therapy | 1e+06 cells | — |
| Subject | anti-CD19 CAR-T cells | Cell therapy | 3e+06 cells | — |