RecruitingEarly Phase 1NCT06939166

Universal Chimeric Antigen Receptor T-Cell (UCAR T-cell) Therapy Targeting CD19/B Cell Maturation Antigen (CD19/BCMA) in Patients With r/r Neurological Autoimmune Diseases

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases


Sponsor

Tianjin Huanhu Hospital

Enrollment

12 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge immune cell therapy called UCAR-T (universal CAR-T cells) that targets the CD19 and BCMA proteins found on immune cells that drive certain autoimmune nerve diseases. Unlike conventional CAR-T made from a patient's own cells, UCAR-T cells come from donor cells engineered in a lab, allowing faster availability. The diseases targeted include neuromyelitis optica (NMO), myasthenia gravis, multiple sclerosis, autoimmune encephalitis, and CIDP. **You may be eligible if...** - You are 18 or older - You have been diagnosed with one of these autoimmune nerve conditions: NMOSD, myasthenia gravis, multiple sclerosis, autoimmune encephalitis, or CIDP - Your disease has relapsed or not responded to previous treatments - Your blood tests show the presence of CD19 or BCMA proteins on your B cells - You are using reliable contraception **You may NOT be eligible if...** - You have a history of severe drug allergies - You have had cancer in the last 5 years - You have significant heart problems - You have active hepatitis B, hepatitis C, HIV, or syphilis - 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

DRUGUCAR T-cell

Universal allogeneic anti-CD19/BCMA CAR T-cells


Locations(1)

Tianjin Huanhu Hospital

Tianjin, China

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NCT06939166


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