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| ID | Type | Description | Link |
|---|---|---|---|
| 2026/4318 | Other Identifier | CSET number (Gustave Roussy ID) |
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This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 CAR-T cells | Biological | The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion | Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either:
| from CAR-T cells infusion to 30 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristina CASTILLA-LLORENTE | Contact | +33(0)142114355 | Cristina.castilla-llorente@gustaveroussy.fr | |
| Timothé DENAËS | Contact | +33(0)142115554 | timothe.denaes@gustaveroussy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy | Villejuif | Val de Marne | 94805 | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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