Clinical Trial

Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases

Recruiting Phase 1/2
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Summary
This study is a phase Ib/IIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor receptor (BAFFR) in refractory neuroimmune diseases. The study design is divided into two parts, the first of which will be given to each patient at 3 incremental dose levels to establish the maximum tolerated dose (MTD). Each disease is expected to enroll 12 patients who meet the inclusion criteria. In the second part, 15 patients per disease will be recruited to further characterize the efficacy of the MTD.
Trial Details
NCT Number NCT07022197
Lead Sponsor Tianjin Medical University General Hospital
Conditions Chronic Inflammatory Demyelinating Polyradiculoneuropathy, NMO Spectrum Disorder, Myasthenia Gravis, Idiopathic Inflammatory Myopathies
Enrollment 27 participants
Start Date 2025-04-10
Primary Completion 2027-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-15