Actively Recruiting
GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms
Led by Zhimin Zhai · Updated on 2025-12-29
24
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
Sponsors
Z
Zhimin Zhai
Lead Sponsor
Z
Zeno Therapeutics Pte. Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of lymphoid neoplasms per WHO-HAEM5 criteria
- Relapsed or refractory disease meeting one of: no partial response after two standard therapy cycles; progression within six months post-response or after six months with no response to first/second-line therapy; relapse after stem cell transplant
- Evidence of EBV infection by one of: EBV DNA ≥ 10³ copies/ml in blood; tumor cells ≥ 10% GP350 positive; serology showing positive EBV antibodies
- At least one evaluable lymphoma lesion or active lytic EBV infection
- ECOG performance status 0-2 and expected survival ≥ 3 months
- Age 18 to 70 years
- Blood counts: ANC ≥ 1.0 × 10⁹/L; hemoglobin > 60 g/L; CD3+ T cells > 0.5 × 10⁹/L; platelets > 30 × 10⁹/L
- Organ function: creatinine clearance ≥ 60 mL/min; ALT/AST ≤ 2× upper limit of normal; total bilirubin ≤ 2× upper limit of normal; LVEF ≥ 50% without pericardial effusion or significant ECG abnormalities; minimal or no pleural/ascitic fluid; oxygen saturation ≥ 95%
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception until last follow-up
- Male participants with fertile partners must agree to effective contraception until last follow-up
- Psychologically stable, able to understand and consent to study procedures and comply with protocol
You will not qualify if you...
- Active hepatitis A, B, or C infection or other uncontrolled severe infections (except EBV)
- History of AIDS or chronic use of immunosuppressants including corticosteroids > 15 mg/day prednisone equivalent
- Cardiac conditions including NYHA Class III/IV heart failure, recent myocardial infarction or bypass surgery within 6 months, serious ventricular arrhythmia or unexplained syncope, severe non-ischemic cardiomyopathy, or cardiac insufficiency with LVEF < 45% within 8 weeks prior to apheresis
- Pregnant or lactating women, or unwillingness to use contraception
- Hepatic or renal impairment: AST/ALT > 3× upper limit of normal, total bilirubin > 3× upper limit of normal, creatinine clearance < 60 mL/min
- History of severe hypersensitivity to study drugs
- Prior stem cell transplant patients must have stopped immunosuppressants for > 6 weeks post-transplant and show no graft-versus-host disease
- Any other condition deemed unsuitable by investigator, such as coagulation disorders or hemolytic anemia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230031
Actively Recruiting
Research Team
Z
Zhimin Zhai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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