RecruitingPhase 2NCT06794008

BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases

An Open, Single-Arm, Single-Center Clinical Study Assessing the Safety and Efficacy of BCMA-CD19 Targeted Chimeric Antigen Receptor T-Cell Therapy in Multiple Refractory Autoimmune Diseases


Sponsor

Peking University People's Hospital

Enrollment

50 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy — immune cells engineered to target two proteins, BCMA and CD19 — as a treatment for serious autoimmune diseases that have not responded to multiple other treatments. These include lupus, Sjögren's syndrome, inflammatory muscle disease, and others. **You may be eligible if...** - You are 18–65 years old and weigh at least 45 kg - You have a confirmed diagnosis of a qualifying autoimmune disease (such as lupus, Sjögren's syndrome, systemic sclerosis, or others) - You have tried and failed multiple standard treatments including steroids and immune-suppressing drugs **You may NOT be eligible if...** - You have an active serious infection - You have a history of heart failure or significant cardiac issues - You are pregnant or breastfeeding 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

DRUGBCMA-CD19 CAR-T therapy

Patients received the BCMA-CD19-targeted CAR-T cells with a dosage of 3×10\^6/kg CAR-T cells per kilogram.


Locations(1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06794008


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