RecruitingPhase 1NCT07093086

Clinical Study of Multi-targeted CAR-T Therapy in Patients With Relapsed/Refractory B-Cell Lymphoma

A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of CD20/CD19/CD22 Multi-targeted Chimeric Antigen Receptor T-cell (CAR-T) Injection in Patients With Relapsed/Refractory B-cell Lymphoma.


Sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Enrollment

20 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.


Eligibility

Min Age: 2 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a multi-targeted CAR-T cell therapy for people with B-cell lymphoma (a type of blood cancer) that has returned or stopped responding to standard treatments. This therapy engineers the patient's own immune cells to attack cancer cells that carry certain proteins (CD19, CD20, and/or CD22). **You may be eligible if...** - You are aged 2 to 75 years old - You have confirmed B-cell lymphoma that has relapsed or not responded after at least two prior treatment regimens - Your tumor tests positive for at least one of CD19, CD20, or CD22 - You are in reasonably good physical condition - You have at least one measurable area of cancer - Your heart, lungs, liver, and kidneys are working adequately **You may NOT be eligible if...** - You have another active cancer (other than cured cancers or those clear for 3+ years) - You recently took steroids or immune-suppressing drugs that could affect the cell therapy - You have active hepatitis B, C, HIV, or syphilis - You have significant uncontrolled heart problems (e.g., recent heart attack, very low pumping function) - You are pregnant or breastfeeding - You have an active autoimmune disease requiring immune suppression 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

DRUGTriple-targeted CAR-T Therapy

Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.


Locations(2)

Hebei Yanda Ludaopei Hospital

Hebei, China

Tongji Hospital of Tongji University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07093086


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