RecruitingNot ApplicableNCT07248163

Universal CAR-T Cell Therapy for NHL

A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting CD19 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma


Sponsor

Bioray Laboratories

Enrollment

6 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, single-arm, open-label clinical study, and the sample size is set to 3-6 subjects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called "universal" CAR-T cell therapy for people with non-Hodgkin lymphoma (NHL), a type of blood cancer. Unlike standard CAR-T therapy, which uses a patient's own cells, this version uses donor cells that can potentially be given to multiple patients. **You may be eligible if...** - You are 18 or older - You have been diagnosed with NHL and your cancer cells test positive for a protein called CD19 - You have at least one measurable tumor - Your heart function is normal (ejection fraction at least 55%) - You have no severe lung problems - Your blood and organ function meet basic health requirements - Your doctors estimate you have at least 3 months to live **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have previously had a stem cell transplant from a donor - You have already received any CAR-T cell therapy or other gene-modified cell treatments - You have previously been treated with therapies targeting the CD19 protein - You have an uncontrolled infection - You have active HIV, hepatitis B or C, or syphilis - You have serious heart, brain, or nervous system conditions - You have an active autoimmune disease requiring immune-suppressing medications 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

DRUGBRL-301

The administered dose is 5×10\^6/kg


Locations(1)

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, China

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NCT07248163


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