drugset / Trial / NCT07670260

GoFast CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma

NCT07670260

Phase 0 Not yet recruiting 9 enrolled Chinese PLA General Hospital
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

EvaluationDrugModalityDoseRoute
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

Indications