drugset / Trial / NCT04214886
CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies
Non-randomizedSequentialOpen-labelTreatment
Summary
In this protocol, the investigators hypothesize that modifying the process of producing CAR+ T-cells can help to improve responses and reduce toxicities. Building on previous in vitro studies that have shown successful production of CAR+ T-cells using a new production approach, the investigators are now studying the ability to produce these CAR+ T-cells and determine how well they work in the clinical setting.
Timeline
- Start
- 2019-12-31
- Primary completion
- 2022-08-11
- Completion
- 2034-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19-CD34 CAR transduced T cells | Cell therapy | 500000 cells/kg | Intravenous |
| Subject | CD19-CD34 CAR transduced T cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CD19-CD34 CAR transduced T cells | Cell therapy | 1.5e+06 cells/kg | Intravenous |
| Subject | CD19-CD34 CAR transduced T cells | Cell therapy | 2e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |