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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
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.
Details
| Lead sponsor | Tianjin Huanhu Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 12 |
| Start date | 2025-06-17 |
| Completion | 2027-10 |
Conditions
- Neuromyelitis Optica Spectrum Disorders
- Myasthenia Gravis
- Multiple Sclerosis
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Autoimmune Encephalitis
Interventions
- UCAR T-cell
Primary outcomes
- The number and severity of dose-limiting toxicity (DLT) events — Within 28 Days After UCAR T-cell Infusion
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. - The total number, incidence, and severity of AEs — Up to 90 days After UCAR T-cell Infusion
Countries
China