RecruitingPhase 1Phase 2NCT07306156

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

Sponsor

Zhimin Zhai

Enrollment

24 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

EBV Associated Lymphoid Neoplasms

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR T-cell therapy — a treatment where a patient's own immune cells are re-engineered to target a protein called GP350 found on certain cancer cells — for people with lymphomas and other blood cancers linked to Epstein-Barr virus (EBV) infection that have returned or not responded to prior treatment. **You may be eligible if...** - You have a confirmed diagnosis of a lymphoid cancer (such as lymphoma) associated with EBV - Your cancer has returned after prior treatment (relapsed) or stopped responding to treatment (refractory) - You have adequate organ function and blood counts - You meet the disease assessment criteria (e.g., did not respond to first-line therapy, progressed within 6 months of response, or have relapsed after transplant) **You may NOT be eligible if...** - You have an active uncontrolled infection - You do not have EBV-associated disease - Your organ function does not meet minimum requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGP350 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.

Locations(1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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NCT07306156