RecruitingPhase 1NCT07526493

Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.

An Open-Label Clinical Study to Evaluate the Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.

Sponsor

Tongji Hospital

Enrollment

6 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Neuromyelitis Optica Spectrum Disorder (NMOSD)Multiple Sclerosis (MS)Myasthenia Gravis (MG)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Autoimmune Encephalitis (AE)Idiopathic Inflammatory Myopathies(IIM)Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)

Summary

This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of recurrent/refractory antibody-mediated neurological autoimmune diseases.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a drug called Fludarabine, and others for people with anti-myelin oligodendrocyte glycoprotein immunoglobulin g antibody-associated disease (mogad), autoimmune encephalitis (ae), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

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

BIOLOGICALUniversal CD19 CAR-γδT Cell Injection

Biological: Allogeneic CD19 CAR-γδT cell following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated

DRUGCyclophosphamide

Subjects will receive cyclophosphamide infusion on Days -5 to -3 prior to cell infusion.

DRUGFludarabine

Subjects will receive fludarabine infusion on Days -5 to -3 prior to cell infusion.

Locations(1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07526493

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