drugset / Trial / NCT03338972
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
Phase 1
Completed
28 enrolled
Fred Hutchinson Cancer Center
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · collabNational Cancer Institute (NCI) · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count in the blood, which may help the infused BCMA CAR-T cells survive and expand.
Timeline
- Start
- 2017-11-29
- Primary completion
- 2021-05-03
- Completion
- 2022-03-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FCARH143 | Cell therapy | 5e+07 cells | Intravenous |
| Subject | FCARH143 | Cell therapy | 1.5e+08 cells | Intravenous |
| Subject | FCARH143 | Cell therapy | 3e+08 cells | Intravenous |
| Subject | FCARH143 | Cell therapy | 4.5e+08 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |