ClinicalTrialsFinder
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

Inclusion Criteria23

  • Diagnosis: Confirmed diagnosis of lymphoid neoplasms according to WHO-HAEM5 (Alaggio R. et al. doi:10.1038/s41375-022-01620-2);
  • Disease Assessment:
  • 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.
  • Performance Status: ECOG score 0-2 and expected survival ≥3 months;
  • Age: 18-70 years, regardless of sex;
  • Hematologic Criteria:
  • Absolute neutrophil count (ANC) ≥1.0×10⁹/L;
  • Hemoglobin \>60 g/L;
  • CD3+ T-cell count \>0.5×10⁹/L;
  • Platelet count \>30×10⁹/L;
  • Organ Function:
  • Creatinine clearance ≥60 mL/min;
  • ALT/AST ≤2× upper limit of normal (ULN);
  • Total bilirubin ≤2× ULN;
  • Left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion, and no clinically significant ECG abnormalities;
  • Minimal or no pleural/ascitic fluid;
  • Oxygen saturation ≥95%;
  • Contraception:
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception until the last follow-up;
  • Male participants with fertile partners must agree to use effective contraception until the last follow-up;
  • Informed Consent: Psychologically stable, capable of understanding the study's purpose and procedures, willing to participate voluntarily, and able to provide signed informed consent and comply with protocol requirements.

Exclusion Criteria20

  • Active Infections: Presence of active hepatitis A, B, or C infection, or other uncontrolled severe active infections (excluding EBV infection);
  • 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;
  • Cardiac Dysfunction:
  • NYHA Class III or IV congestive heart failure;
  • Myocardial infarction or coronary artery bypass grafting within the past 6 months;
  • Clinically significant ventricular arrhythmia or unexplained syncope;
  • History of severe non-ischemic cardiomyopathy;
  • Cardiac insufficiency (left ventricular ejection fraction \<45%) within 8 weeks prior to apheresis;
  • Pregnancy/Contraception:
  • Pregnant or lactating women;
  • Participants (male or female) unwilling to use contraception;
  • Hepatic/Renal Impairment:
  • AST/ALT \>3× upper limit of normal (ULN);
  • Total bilirubin \>3× ULN;
  • Creatinine clearance \<60 mL/min;
  • Allergies: History of severe hypersensitivity to any study drugs;
  • Prior Stem Cell Transplant: Must have discontinued immunosuppressants for \>6 weeks post-transplant with no signs of graft-versus-host disease (GVHD);
  • Other Exclusionary Conditions: Any other condition deemed unsuitable by the investigator (e.g., coagulation disorders, hemolytic anemia, etc.).

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07306156