drugset / Trial / NCT04844086
RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infused at the varied doses of T cells.
Timeline
- Start
- 2021-03-02
- Primary completion
- 2022-05-12
- Completion
- 2022-05-12
Outcome
Outcome not reported
Stopped: “CAR-T manufacturing technology can not meet the dose requirement for clinical patients.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RPM CD19-mbIL15-CAR-T cells | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |