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NOT YET RECRUITING
NCT07670260
EARLY_PHASE1

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

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

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.

Official title: Exploratory Clinical Study of GoFast CAR T-Cell Platform Targeting CD19 CAR T-Cell Therapy for Recurrent Refractory B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-06-30

Completion Date

2028-06-30

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

GoFast CD19 CAR T Cells

GoFast CD19 CAR T cells are autologous CD19-targeted chimeric antigen receptor T cells prepared using the GoFast CAR T-cell platform. Participants will receive lymphodepleting chemotherapy with fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 from Day -5 to Day -3, followed by intravenous infusion of GoFast CD19 CAR T cells according to the assigned dose cohort: 0.3 × 10\^6 cells/kg, 0.6 × 10\^6 cells/kg, or 1.2 × 10\^6 cells/kg.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China