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RecruitingPhase 1Phase 2NCT07022197

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

Sponsor

Tianjin Medical University General Hospital

Enrollment

27 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Myasthenia GravisNMO Spectrum DisorderChronic Inflammatory Demyelinating PolyradiculoneuropathyIdiopathic Inflammatory Myopathies

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BAFF-R CART for people with chronic inflammatory demyelinating polyradiculoneuropathy, idiopathic inflammatory myopathies, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBAFF-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.

Locations(1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

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NCT07022197

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