GP350 CAR-T for Relapse/Refractory and Epstein-Barr Virus Infection Associated Lymphoid Neoplasms

NCT07306156 | Recruiting Phase 1

• 1 other identifier: TXB2025-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

EBV Associated Lymphoid Neoplasms

Keywords

LAHS; EBV; Lymphoma; Lymphoid neoplasms; CAR-T

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Within 3 months post-infusion

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  1 yesr post CAR-T infusion

• Overall Survival (OS)

  1 yesr post CAR-T infusion

Study Arms (1)

CAR-T Treatment

EXPERIMENTAL

Biological: GP350 CAR-T

Interventions

GP350 CAR-T BIOLOGICAL

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.

CAR-T Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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);

Sponsors & Collaborators

• Zhimin Zhai: lead
• Zeno Therapeutics Pte. Ltd: collaborator

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230031, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Zhimin Zhai, MD

CONTACT

+86-0551-63869571; zzzm889@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Hematology Department

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 29, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 10, 2030
• Study Completion (Estimated): November 20, 2032
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)