Loading clinical trials...

GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT07306156•Zhimin Zhai

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
•2. Disease Assessment:
•1. 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.
•2. 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.
•3. At least one evaluable lymphoma lesion according to Lugano criteria, or confirmed active lytic EBV infection.
•3. Performance Status: ECOG score 0-2 and expected survival ≥3 months;
•4. Age: 18-70 years, regardless of sex;
•5. Hematologic Criteria:
•* Absolute neutrophil count (ANC) ≥1.0×10⁹/L;
•* Hemoglobin \>60 g/L;
+13 more criteria

Exclusion Criteria

•1. Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
•2. Immunosuppression:
•* History of acquired immunodeficiency syndrome (AIDS);
•* Chronic use of immunosuppressants (including corticosteroids at doses equivalent to \>15 mg/day of prednisone) for other conditions;
•3. Cardiac Dysfunction:
•1. NYHA Class III or IV congestive heart failure;
•2. Myocardial infarction or coronary artery bypass grafting within the past 6 months;
•3. Clinically significant ventricular arrhythmia or unexplained syncope;
•4. History of severe non-ischemic cardiomyopathy;
•5. Cardiac insufficiency (left ventricular ejection fraction \<45%) within 8 weeks prior to apheresis;
+10 more criteria

Locations (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

November 10, 2025

Primary Completion Date

November 10, 2030

Completion Date

November 20, 2032

Last Updated

December 29, 2025

Enrollment

ESTIMATED participants

Conditions

EBV Associated Lymphoid Neoplasms

Interventions

GP350 CAR-T

BIOLOGICAL

Contacts

Zhimin Zhai, MD

CONTACT

+86-0551-63869571 zzzm889@163.com