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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

April 10, 2025

Primary Completion Date

December 30, 2027

Study Completion Date

December 30, 2027

Conditions
Chronic Inflammatory Demyelinating PolyradiculoneuropathyNMO Spectrum DisorderMyasthenia GravisIdiopathic Inflammatory Myopathies
Interventions
DRUG

BAFF-R CART

"Biological: BAFF-R CART cells Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture BAFF-R CART cells, during which cyclophosphamide will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with BAFF-R CART cells by intravenous (IV) infusion. The initial dose of 0.5×10\^6 CART cells/kg will be infused on day 0.~Drug: Cyclophosphamide and fludarabine Subjects will receive one 3-day cycle of lymphodepletion starting 4 days prior to BAFF-R CART cells infusion on Day 0.~Subjects will be given IV infusion of cyclophosphamide 250 mg/m2/day on day -5, -4 and -3, and fludarabine 30 mg/m2 over 30 minutes administered immediately after cyclophosphamide."

Trial Locations (1)

300052

RECRUITING

Tianjin Medical University General Hospital, Tianjin

All Listed Sponsors
lead

Tianjin Medical University General Hospital

OTHER