RecruitingPhase 1Phase 2NCT07022964

CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas

A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas

Sponsor

Beijing GoBroad Hospital

Enrollment

36 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

T-cell Non-Hodgkin Lymphoma T-cell Lymphoma (PTCL and CTCL)

Summary

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Eligibility

Min Age: 14 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy (CAR T-cell therapy) for people with T-cell lymphoma — a type of blood cancer — that has come back or stopped responding to standard chemotherapy. **You may be eligible if...** - You are between 14 and 70 years old - You have been diagnosed with CD7-positive T-cell lymphoma that has relapsed or is no longer responding to treatment - You have already received standard chemotherapy and there are no other good treatment options left - You are in reasonably good health (able to do most daily activities) - Your life expectancy is at least 60 days **You may NOT be eligible if...** - You previously had a stem cell transplant from a donor but stem cells are not available - You have certain serious infections or other major health conditions that would make this treatment unsafe - You cannot give informed consent (or your guardian cannot, if you are under 18) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCD5 CAR-T cells infusion

Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.