RecruitingEarly Phase 1NCT06548607

Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases


Sponsor

Nanjing Bioheng Biotech Co., Ltd.

Enrollment

20 participants

Start Date

Sep 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge immune therapy called CAR-T cell therapy — where a patient's own immune cells are reprogrammed to attack disease — for people with serious autoimmune diseases. The CAR-T cells are designed to target CD19 or both CD19 and BCMA proteins found on the immune cells that are mistakenly attacking the body. **You may be eligible if...** - You are between 18 and 70 years old with a confirmed autoimmune disease - Your liver, kidney, blood, and heart function meet the required levels - Your oxygen levels are acceptable - You have tried other treatments without success **You may NOT be eligible if...** - You have active uncontrolled infections, including HIV or hepatitis - You have had a prior organ transplant or stem cell transplant - You are pregnant or breastfeeding - You have severe heart or lung problems - You have active cancer - Your organ function is too impaired for this intensive therapy 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

DRUGCD19 or CD19-BCMA CAR-T

CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.


Locations(1)

The Third the People's Hospital of Bengbu

Bengbu, Anhui, China

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NCT06548607


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