NCT07526493

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Universal CD19 CAR-γδT Cell Injection	Biological: Allogeneic CD19 CAR-γδT cell following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated
DRUG	Cyclophosphamide	Subjects will receive cyclophosphamide infusion on Days -5 to -3 prior to cell infusion.
DRUG	Fludarabine	Subjects will receive fludarabine infusion on Days -5 to -3 prior to cell infusion.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China