RecruitingPhase 1Phase 2NCT07097207

Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma

Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma


Sponsor

Shenzhen University General Hospital

Enrollment

20 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 3. Participant Intervention: * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy — called CD19/CD20 CAR-T — for people with B-cell lymphoma (a blood cancer) that has come back or stopped responding to standard treatments. The therapy takes a patient's own immune cells, engineers them to attack cancer cells, and infuses them back. **You may be eligible if...** - You are aged 15–75 - You have B-cell lymphoma that has relapsed or is no longer responding to treatment - You have already tried at least two standard treatment regimens - Your tumor cells express a protein called CD20 - You are well enough to carry out daily activities (ECOG score 0–2) - Your heart, lungs, liver, and kidneys are working well enough **You may NOT be eligible if...** - You have already received CAR-T cell therapy - You have severe heart failure or heart disease - You have HIV, active hepatitis B or C, or syphilis - You have an uncontrolled active infection - You have an autoimmune disease requiring immunosuppressants - You are pregnant, breastfeeding, or planning pregnancy during the trial - You participated in another clinical study within the past 3 months 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

COMBINATION_PRODUCTCAR-T cell

Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T or CD19-CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.


Locations(1)

Shenzhen University General Hospital

Shenzhen, Other (Non U.s.), China

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NCT07097207


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