RecruitingPhase 1Phase 2NCT06925464

CD7 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

Apr 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 CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 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 CD7 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 CD7 CAR T-cell therapy — a treatment where a patient's own immune cells are re-engineered to recognise and attack cancer cells — in patients with T-cell lymphoma (a type of blood cancer) that has come back or stopped responding to standard treatment. **You may be eligible if...** - You are between 14 and 70 years old - You have a type of T-cell lymphoma that is CD7-positive (confirmed by testing) - Your cancer has relapsed or is refractory (stopped responding) to standard chemotherapy - Your general health is reasonably good (ECOG score 0–2) and your expected survival is at least 60 days **You may NOT be eligible if...** - Your general health is too poor for the treatment - You have active infection or other conditions that would prevent the therapy - You are pregnant or planning to have children during the trial period - You cannot provide informed consent 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

DRUGCD7 CAR-T cells infusion

Approximately 3-5 days prior to CD7 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.