RecruitingEarly Phase 1NCT06532643

Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

An Exploratory Clinical Study of Autologous Anti-CD20/CD30 Chimeric Antigen Receptor T Cells (anti-CD20/CD30 CAR-T Cells) in Subjects with Relapsed/Refractory Lymphoma


Sponsor

Shanghai First Song Biotechnology Co., LTD

Enrollment

9 participants

Start Date

Aug 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.


Eligibility

Min Age: 14 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cell therapy called CAR-T therapy — where a patient's own immune cells (T-cells) are taken out, genetically modified to attack cancer, and put back in — for people with lymphoma that has relapsed (come back) or stopped responding to standard treatments. This particular CAR-T therapy targets two proteins on lymphoma cells at once: CD20 and CD30, making it potentially more effective for hard-to-treat cases. **You may be eligible if...** - You are 14 to 69 years old with relapsed or refractory lymphoma - Your lymphoma has not responded to current standard treatments, including stem cell transplant if you had one - You have measurable lymphoma on a scan - Your blood counts and organ function (heart, lungs, kidneys, liver) meet minimum thresholds **You may NOT be eligible if...** - You have active or uncontrolled infection - You have serious heart, lung, liver, or kidney problems - You are pregnant or breastfeeding - You are currently receiving immunosuppressive drugs (like high-dose steroids) - You have significant autoimmune conditions 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

GENETICanti-CD20/CD30-CAR-T cells

Each subject will be infused with single dose of anti-CD20/CD30-CAR-T cells. A classic "3+3" dose escalation will be employed.

DRUGFludarabine

Fludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.

DRUGCyclophosphamide

Cyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to the infusion of anti-CD20/CD30-CAR-T cells.


Locations(1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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NCT06532643


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