drugset / Trial / NCT07503353
A Phase 1/2 Study of T-cell Expressing a Novel CD19 Chimeric-Antigen Receptor (SHB-02-CD19) in Patients With CD19-expressing B-cell Malignancies
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I/II trial of SHB-02-CD19, T-cell expressing an anti-CD19 Chimeric-Antigen-Receptor (CAR) in patients with CD19 expressing B-cell malignancies. This trial is an open label, single-arm, for pediatric and adult patients with relapsed/refractory B-cell malignancies.
Timeline
- Start
- 2026-06
- Primary completion
- 2029-06
- Completion
- 2030-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SHB-02-CD19 | Cell therapy | 250000 cells/kg | — |
| Subject | SHB-02-CD19 | Cell therapy | 500000 cells/kg | — |
| Subject | SHB-02-CD19 | Cell therapy | 1e+06 cells/kg | — |