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This is an open label, single-site, dose-escalation study in up to 18 participants with refractory rheumatoid arthritis. This study aims to evaluate the safety and efficacy of the treatment with Anti-CD19 CART.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD19 CART | Experimental | Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-CD19 CART will be infused on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19 CART cells will be given IV at split doses. | Drug | Split intravenous infusion of Anti-CD19 CART cells of (Dose escalating infusion of 1 - 6 x10^6 CART cells/kg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The persistence, accumulation, and migration of Anti-CD19 CART cells | Assessing the trafficking of Anti-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. | Day-1, 1, 3, 5, 7, 9, 11, 14, 21, 28 and Month 2, 3, 6, 9, 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Chen Professor of medicine, M.D. | Contact | 860551-62283843 | doczchen@gmail.com | |
| Zhu Chen Professor, M.D. | Contact | 860551-62283843 | doczchen@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Siweikang Therapeutic Co.Ltd | Recruiting | Changsha | Hunan | 410119 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Erythrocyte Sedimentation Rate | To evaluate RA disease activity | Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12 |
| 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 |
| Swollen and tender joint count | To evaluate RA disease activity | Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12 |
| Visual Analogue Scale | The visual analogue scale is used to assess pain. The basic method is to use a swimming scale about 10cm long, marked with 10 scales on one side, and the two ends are "0" and "10" respectively, 0 points represent no pain, and 10 points represent the most unbearable pain. | Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |