An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
NCT Number: NCT06503224
Acronym: SCAR02
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Autoimmune Diseases
Interventions: DRUG: Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-09
Completion Date: 2028-04-30
Locations: Hunan Siweikang Therapeutic Co.Ltd, Changsha, Hunan, 410119, China

Summary:
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART

Primary Outcome Measures: Adverse events, Total number, incidence and severity of adverse events (AEs) in patients of SCAR02 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus., up to 2 years
Secondary Outcome Measures: The persistence, accumulation, and migration of Anti-BCMA and CD19 CART cells, Assessing the trafficking of Anti-BCMA and CD19 CART cells in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline., up to 2 years|Erythrocyte Sedimentation Rate, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|American College of Rheumatology (ACR) criteria 20, 50, 70 response rate, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Swollen and tender joint count, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Visual Analogue Scale, To evaluate RA disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2000) from baseline, Range \[0, 105\]，higher score represents worse disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in the Physician Global Assessment (PGA) score from baseline, Range \[0, 3\]，higher score represents worse disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in the BILAG-2004 score from baseline, Range \[0, 72\]，higher score represents worse disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in immunological indexes from baseline, Serum IgA, IgG and IgM will be evaluated, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in level of anti-double stranded DNA (dsDNA) antibody in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in levels of complement in peripheral blood from baseline, To evaluate SLE disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24, To evaluate SLE disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in levels of anti-Ro/SSA antibodies in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in levels of Changes in levels of anti-Ro/SSA antibodies in peripheral blood from baseline in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in levels of Changes in levels of RF in peripheral blood from baseline in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in levels of Changes in levels of anti-topoisomerase I antibody in peripheral blood from baseline in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline, Change in Health Assessment Questionnaire Disability Index (HAQ-DI) describes the patient's self-assessed degree of disability. HAQ-DI comprises 8 categories of questions rated from 0 to 3, where 3 indicates the worst degree of disability., Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24|Changes in levels of Changes in levels of anti-RNA polymerase III antibody in peripheral blood from baseline in peripheral blood from baseline, To evaluate disease activity, Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24