RecruitingPhase 2NCT05941156

Clinical Study of Anti-CD56-CAR-T in the Treatment of Relapsed/Refractory NK/T Cell Lymphoma /NK Cell Leukemia

Single-center, Open, One-arm Clinical Study of the Safety and Efficacy of Anti-CD56-CAR T Therapy in Relapsed Refractory NK/T Cell Lymphoma /NK Cell Leukemia


Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

20 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety and efficacy of anti-CD56-CAR T in the treatment of relapsed refractory NK/T cell lymphoma /NK cell leukemia


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy (immune cells engineered to attack cancer) that targets a protein called CD56, for people with relapsed or treatment-resistant NK/T-cell lymphoma or NK cell leukemia — rare and aggressive blood cancers. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with NK/T-cell lymphoma or NK cell leukemia confirmed by pathology or flow cytometry - Your cancer has come back or stopped responding to prior treatments - You have received at least two prior lines of treatment - Your general health is well enough to tolerate this therapy **You may NOT be eligible if...** - You have not received prior treatment for your cancer - You have active serious infections (including HIV, hepatitis B or C) - You have other significant organ problems (heart, liver, kidneys) - You have had a recent stem cell transplant 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAnti-CD56 CAR T

CAR T cells were pretreated at -5 days before retransfusion (FC regimen: fludarabine: 30mg/m2×3 days, cyclophosphamide: 750mg/m2×1 day). Anti CD56-CAR T cells were transfused back to the patient 2 days after the end of chemotherapy. 30 to 60 minutes before CAR T cell infusion, patients were given 325 to 650 mg of acetaminophen orally to prevent infusion-related reactions; If fever occurred on the day of CAR T cell infusion, lasted less than 24 hours, and had no other toxicity, it was attributed to the infusion T cell response.


Locations(1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05941156


Related Trials