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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-BCMA and CD19 CART | Experimental | Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis. | Drug | A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 0.5-3 x10^6 CART cells/kg). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients with rheumatoid arthritis must also meet the following enrollment criteria:
Patients with SLE will also be required to meet the following enrollment criteria:
Patients with dry syndrome were also required to meet the following enrollment criteria:
Patients with systemic sclerosis were also required to meet the following enrollment criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhu chen, M.D | Contact | 860551-62283843 | doczchen@gmail.com | |
| xiaojuan zhao, master | Contact | +86 15955139303 | zhaoxiaojuan198694@163.com |
| Name | Affiliation | Role |
|---|---|---|
| zhu chen, M.D | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
| xingbing wang, M.D | The First Affiliated Hospital of University of Science and Technology of China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Siweikang Therapeutic Co.Ltd | Recruiting | Changsha | Hunan | 410119 | China |
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| 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 |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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