Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r/r NHL
Summary
CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. A novel version of the CAR-γδT product by gene editing (QH103E) that has been validated for resistance to alloreactive T cell killing and enhancement of memory efficacy will be used in this study. This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) will be enrolled in the study and receive QH103E product infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of QH103E in patients with r/r B-cell NHL.
Timeline
- Start
- 2025-07-27
- Primary completion
- 2027-03-01
- Completion
- 2028-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogenic CD19 CAR-γδT cell | Cell therapy | 1 cells/kg | — |
| Subject | Allogenic CD19 CAR-γδT cell | Cell therapy | 3 cells/kg | — |
| Subject | Allogenic CD19 CAR-γδT cell | Cell therapy | 6 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 50 mg/m2 | Intravenous |