OncoMatch/Clinical Trials/NCT04561557
Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
Is NCT04561557 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including CT103A cells and Cyclophosphamide and fludarabine for autoimmune diseases.
Treatment: CT103A cells · Cyclophosphamide and fludarabine — Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed/refractory antibody-mediated idiopathic inflammatory diseases.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: AQP4 IgG positive
AQP4-IgG-positive NMOSD
Required: MOG antibody positive
documented positive serum MOG Ab test using a cell-based assay (CBA)
Required: VEGF >2 ULN (>2 ULN)
VEGF > 2 ULN (POEMS syndrome)
Prior therapy
Must have received: immunosuppressant — disease-specific, see source_text
At least one kind of immunosuppressant has been used for more than one year with poorly-controlled symptoms (NMOSD); at least one immunosuppressant for standardized treatment for more than 1 year (MG); standardized use of at least one first-line therapy for more than 3 months (CIDP); corticosteroid therapy and standardized use of at least one immunosuppressant/modulator for more than 3 months (IIM); previously standardized use of corticosteroid, at least one immunosuppressant/modulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance (autoimmune encephalitis, MOGAD); no response to traditional regimens treatment including corticosteroid, chemotherapy, protease inhibitor or inability to tolerate the above traditional regimens (POEMS syndrome)
Cannot have received: alemtuzumab (alemtuzumab)
Patients were treated with alemtuzumab within 6 months prior to apheresis
Cannot have received: purine analog (fludarabine, cladribine)
Patients were treated with fludarabine or cladribine within 3 months prior to apheresis
Cannot have received: thymectomy
History of thymectomy within 12 months prior to CT103A infusion
Lab requirements
Blood counts
absolute neutrophil count ≥ 2×10^9/L (or normal lower limit set by the central lab), platelets ≥ 100 × 10^9/L, hemoglobin ≥ 100 g/L
Kidney function
CrCl ≥ 60 ml/min/1.73m2
Liver function
total serum bilirubin, ALT and AST must be ≤ 1.5x the institutional normal upper limit (ULN)
Cardiac function
Echocardiography suggests LVEF≥ 50%
Enrolled subjects must have satisfactory organ function and laboratory findings as defined by the following: ... Echocardiography suggests LVEF≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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