RecruitingEarly Phase 1NCT07246096

Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases


Sponsor

Changhai Hospital

Enrollment

60 participants

Start Date

Feb 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of CAR-T cell therapy (where a patient's own immune cells are engineered to attack disease) that targets two proteins — CD19 and BCMA — for treating severe, treatment-resistant autoimmune diseases such as lupus, myositis, and systemic sclerosis. CAR-T therapy has shown promise in autoimmune diseases where the immune system is attacking the body itself. **You may be eligible if...** - You are 18 to 70 years old - You have a severe autoimmune disease (such as systemic lupus erythematosus, inflammatory myopathy, or systemic sclerosis) that has not responded to standard treatments - Your organ function (blood counts, liver, kidneys, heart) meets the required levels **You may NOT be eligible if...** - You have active serious infections (HIV, active hepatitis B/C) - You have significant heart failure or other major organ failure - You are pregnant or breastfeeding - You have active cancer (other than the condition being treated) 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALanti-CD19/BCMA U CAR T cells

Patients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Dose escalation will be performed for the single dose injection of anti-CD19/BCMA CAR T cells (KN3601)


Locations(1)

Changhai Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07246096


Related Trials