Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
Summary
The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.
Timeline
- Start
- 2020-04-01
- Primary completion
- 2021-04-01
- Completion
- 2022-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anti-CD19 UCAR-T cells | Cell therapy | 1e+07 cells/kg | — |
| Subject | Anti-CD19 UCAR-T cells | Cell therapy | 3e+07 cells/kg | — |
| Subject | Anti-CD19 UCAR-T cells | Cell therapy | 5e+07 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Melphalan | Small molecule | 50 mg/m2 | — |
| Background | Melphalan | Small molecule | 70 mg/m2 | — |