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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
(from sponsor)		 Chronic Inflammatory Demyelinating Polyradiculoneuropathy, NMO Spectrum Disorder, Myasthenia Gravis, Idiopathic Inflammatory Myopathies
Related terms Myasthenia Gravis, Myositis, Neuromyelitis Optica, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov