NCT07306156

GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms

GP350 CAR-T Cells for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms, an Open-label, Single-arm Clinical Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zhimin Zhai · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• EBV Associated Lymphoid Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	GP350 CAR-T	Lymphodepletion chemotherapy with fludarabine (25 mg/m²/day) and cyclophosphamide (250 mg/m²/day) should be administered for 2-3 consecutive days, with the final dose completed 48 hours before infusion. Alternatively, investigators may individualize this regimen based on the subject's specific clinical circumstances. The target dose of GP350 CAR-T cells is 1.0-5.0×10⁶ CAR-T cells per kilogram of body weight, administered via intravenous injection. (The actual infused dose is allowed to vary within ±20% from the target dose, depending on the as-released product yield) Patients with less than partial response AND without \> Grade 2 CRS or any ICANS may receive 1 to 2 additional infusion of GP350 CAR-T cells at the same dose.

Timeline

• Start date: 2025-11-10
• Primary completion: 2030-11-10
• Completion: 2032-11-20
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: China