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

NCT07306156 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

GP350 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.

Sponsors & Collaborators

  • Zeno Therapeutics Pte. Ltd

    collaborator UNKNOWN

  • Zhimin Zhai

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2030-11-10
Completion
2032-11-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306156 on ClinicalTrials.gov