A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
Trial Parameters
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Brief Summary
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: 1. Patient is ≥ 18 years old, and ≤65 years of age, at time of screening visit. 2. Diagnosis of MS according to the 2017 McDonald Criteria. 3. Progressive MS by 2014 Lublin MS phenotypic criteria. 4. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least four weeks prior to treatment. 5. Presence of anti EBV antibodies. 6. Organ and Marrow Function * Absolute neutrophil count (ANC) ≥ 2000/uL. * Platelet count ≥ 150,000/uL. * Absolute lymphocyte count ≥ 1000/uL. * Serum immunoglobulin G (IgG) ≥ 500mg/dL. * Hemoglobin ≥ 9 g/dL. * Adequate renal, hepatic, pulmonary and cardiac function defined as: * Creatinine ≤ 2mg/dL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min. * Serum alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN). * Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrom