Open-Label Phase 1 Study of QH103 Cell Injection for Treating Relapsed or Resistant Antibody-Mediated Neurological Autoimmune Diseases

What this Trial Is About

Researchers are evaluating the safety and tolerability of QH103, a Universal CD19 CAR-T cell injection, in treating patients with relapsed or refractory antibody-mediated neurological autoimmune diseases. This open-label, exploratory clinical trial uses a dose escalation approach based on a 33 design to study this treatment in adults aged 18 to 75 years. The trial targets various neurological autoimmune conditions, including multiple sclerosis, neuromyelitis optica spectrum disorder, autoimmune encephalitis, chronic inflammatory demyelinating polyneuropathy, myasthenia gravis, MOG antibody-associated disease, and idiopathic inflammatory myopathies. Participants will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine infusions from five to three days before the cell infusion. Then, they will receive the QH103 cell injection. This phase 1 study monitors participants for adverse events and dose-limiting toxicities within 28 days after the first infusion and follows pharmacokinetics and pharmacodynamics for 12 months. The pharmacodynamics focus on changes in cytokines and chemokines over time, while pharmacokinetics measure the number and copy number of the CD19 CAR-T cells. Throughout the study, participants will be closely monitored with safety assessments and laboratory tests for up to 12 months. Researchers will record any adverse events and evaluate the treatments impact on immune system markers. Participants must commit to contraception requirements during and after the study. The total study duration and follow-up aim to provide comprehensive data on safety, tolerability, and biological responses to this investigational treatment in this patient population.

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