RecruitingPhase 1NCT06249438

A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy


Sponsor

RenJi Hospital

Enrollment

30 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy called C-CAR168 for people with severe autoimmune diseases that have not responded to standard treatments. CAR-T therapy reprograms immune cells to reduce harmful immune activity. The diseases targeted include lupus, multiple sclerosis, myasthenia gravis, and other serious autoimmune conditions. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with lupus (SLE), immune-mediated necrotizing myopathy, neuromyelitis optica, multiple sclerosis, myasthenia gravis, or systemic sclerosis for at least 6 months - Your disease remains active or has relapsed despite at least two immunosuppressant treatments - Your organ function is adequate **You may NOT be eligible if...** - You have active hepatitis B, hepatitis C, or HIV infection - You have had recent serious infections - You have certain cancers or conditions that would make CAR-T therapy unsafe - Your disease has not been formally diagnosed for at least 6 months 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

BIOLOGICALCD20/BCMA-directed CAR-T cells

Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously


Locations(1)

Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University

Shanghai, Shanghai Municipality, China

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NCT06249438


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