RecruitingNot ApplicableNCT07052565

CAR-T Cells Therapy for Patients With Autoimmune Diseases

An Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases


Sponsor

Anhui Provincial Hospital

Enrollment

18 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a cutting-edge immune cell therapy called CAR-T cells — where your own immune cells are reprogrammed in the lab to fight disease — in people with severe autoimmune conditions like rheumatoid arthritis, lupus, Sjogren's syndrome, or systemic sclerosis that haven't responded well to standard treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rheumatoid arthritis, lupus (SLE), Sjogren's syndrome, or systemic sclerosis - Your disease is still active despite trying multiple standard medications - Your blood counts and organ function (liver, kidneys) meet minimum health requirements - You are not pregnant and agree to use contraception for at least 2 years after treatment **You may NOT be eligible if...** - You have a serious neurological condition (e.g., stroke, epilepsy, dementia) - You have significant heart disease - You have a history of cancer - You have an active or uncontrolled infection (including HIV, hepatitis B/C, tuberculosis) - You have had an organ or bone marrow transplant - You are currently pregnant or breastfeeding - You have end-stage kidney failure 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

DRUGAnti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis

A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10\^5 CART cells/kg)


Locations(1)

Anhui Provincial Hospital

Hefei, China

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NCT07052565


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