OncoMatch/Clinical Trials/NCT07022197
Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases
Is NCT07022197 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BAFF-R CART for chronic inflammatory demyelinating polyradiculoneuropathy.
Treatment: BAFF-R CART — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: immunosuppressive agent
Poor symptom control on at least three immunosuppressive agents for more than one year
Cannot have received: rituximab (rituximab)
received prior treatment with rituximab within 6 months prior to baseline
Cannot have received: IL-6 inhibitor (tolizumab)
received tolizumab within 3 months prior to baseline
Cannot have received: C5 inhibitor (eculizumab)
received eculizumab within 3 months prior to baseline
Cannot have received: intravenous human immunoglobulin (intravenous human immunoglobulin)
received intravenous human immunoglobulin within 4 weeks prior to baseline
Cannot have received: plasma exchange (plasma exchange)
received plasma exchange within 4 weeks prior to baseline
Cannot have received: immunotherapy
undergone immunotherapy within 4 weeks prior to baseline
Cannot have received: blood transfusion
receiving blood transfusion therapy 4 weeks prior to baseline or during the screening period
Lab requirements
Blood counts
CD19+ B cell count < 40 cells/µL excluded
Kidney function
eGFR < 45 mL/min/1.73 m2 excluded
Liver function
AST or ALT > 3x ULN; total bilirubin > 1.5x ULN excluded
Elevated liver enzymes: AST or ALT > 3x ULN; total bilirubin > 1.5x ULN; eGFR < 45 mL/min/1.73 m2; CD19+ B cell count < 40 cells/µL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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