drugset / Trial / NCT07306156
GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1/Phase 2 open-label, single-arm clinical study of GP350 CAR-T for Relapse/Refractory and Epstein-Barr virus infection associated lymphoid neoplasms. Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy, and an intravenous infusion of CAR-T cells. Each participant will proceed through the following study procedures: * Screening * Enrollment/Leukapheresis * Conditioning chemotherapy * CAR T treatment * Post-treatment assessment * Long-term follow-up
Timeline
- Start
- 2025-11-10
- Primary completion
- 2030-11-10
- Completion
- 2032-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GP350 CAR-T | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | GP350 CAR-T | Cell therapy | 5e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 250 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |