drugset / Trial / NCT07670260
GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an investigator-initiated, prospective, open-label exploratory clinical study designed to evaluate the safety and preliminary efficacy of GoFast CD19 CAR T-cell therapy in adult patients with recurrent or refractory B-cell lymphoma. Eligible patients will undergo screening, baseline assessment, peripheral blood or leukapheresis collection, lymphodepleting chemotherapy, and intravenous infusion of GoFast CD19 CAR T cells. The study plans to enroll 9 participants using a sequential dose-escalation design. The primary outcome is objective response rate, and secondary outcomes include complete remission rate, overall survival, progression-related survival outcomes, duration of response, MRD negativity, and adverse events.
Timeline
- Start
- 2026-06-30
- Primary completion
- 2027-09-30
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19-targeted CAR-T cells | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | CD19-targeted CAR-T cells | Cell therapy | 600000 cells/kg | Intravenous |
| Subject | CD19-targeted CAR-T cells | Cell therapy | 1.2e+06 cells/kg | Intravenous |