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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGOverall Response Rate (ORR)
The percentage of patients with complete response (CR) and partial response (PR) according to the RECIL 2017 criteria determined by the study investigators
Time frame: Month 12 post CAR-T infusion
EBV DNA clearance rate
Defined as the proportion of patients achieving two consecutive negative tests in plasma or whole blood at least 7 days apart following treatment, relative to the total treated population
Time frame: Month 12 post CAR-T infusion
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as an adverse event that occurs or worsens after receiving the first dose of the trial drug
Time frame: Within 3 months post-infusion
Progression-Free Survival (PFS)
PFS is defined as the time from the GP350 CAR-T infusion date to the date of disease progression
Time frame: 1 yesr post CAR-T infusion
Overall Survival (OS)
OS is the time from date of GP350 CAR-T infusion to the date of death due to any reason
Time frame: 1 yesr post CAR-T infusion
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