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
Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
Criteria for Relapsed/Refractory lymphoid neoplasms: Meeting any one of the following three conditions: ① Failure to achieve at least a partial response (PR) per Lugano criteria after two cycles of standard first-line therapy; ② Disease progression within six months after achieving a response to first-line therapy, or progression after six months with no response to the original first-line or second-line regimen; ③ Relapse after hematopoietic stem cell transplantation.
Criteria for EBV Infection: Meeting any one of the following three conditions: ① Peripheral blood (plasma or whole blood) EBV DNA load ≥ 10³ copies/ml by quantitative PCR; ②Tumor cell GP350 positivity (≥10% of tumor cells by immunohistochemistry or flow cytometry); ③ Serological detection of EBV antibodies indicating any of the following: positive anti-VCA-IgM; positive anti-EA-IgG; or simultaneous positivity for anti-VCA-IgM, anti-VCA-IgG, and anti-EBNA-IgG.
At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.
Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
History of acquired immunodeficiency syndrome (AIDS);
Chronic use of immunosuppressants (including corticosteroids at doses equivalent to >15 mg/day of prednisone) for other conditions;
NYHA Class III or IV congestive heart failure;
Single group
GP350 CAR-T
Biological/VaccineLymphodepletion 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.
Overall 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
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
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
Progression-Free Survival (PFS)
PFS is defined as the time from the GP350 CAR-T infusion date to the date of disease progression
Overall Survival (OS)
OS is the time from date of GP350 CAR-T infusion to the date of death due to any reason
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Zhimin Zhai
Lead sponsor
The Second Hospital of Anhui Medical University
Sponsor institution
Zeno Therapeutics Pte. Ltd
Collaborator
