RecruitingPhase 1NCT06909474

Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies

Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory T-Cell Hematologic Malignancies


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

15 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy called CAR-NK (using natural killer cells engineered to target a protein called CD5) in people with relapsed or refractory T-cell leukemia or T-cell lymphoma — cancers that are difficult to treat and have come back or stopped responding to standard treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma - Your cancer has relapsed (come back) or is refractory (not responding) after multiple prior treatments - For T-ALL: your cancer came back within 12 months of achieving remission, failed standard induction, or relapsed after a stem cell transplant **You may NOT be eligible if...** - You have not yet tried standard treatments - Your cancer does not express the CD5 protein target - You have serious organ dysfunction that would make the treatment unsafe 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

BIOLOGICALAnti-CD5 CAR NK cells

Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.


Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

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NCT06909474