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This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Descartes-08 | Other | Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Descartes-08 | Drug | Autologous T-cells expressing a chimeric antigen receptor directed to BCMA |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE) | Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia. | Day -59 to Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profound Research LLC | Oceanside | California | 92056 | United States |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Day -59 to Month 12 |
| Assess the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI) | Assessment of whether participants meet the Systemic Lupus Erythematosus Responder Index (SRI) criteria (Yes/No) at various timepoints up to month 12 follow up visit. | Day -59 to Month 12 |
| Assess the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) | Assessment of whether participants meet the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) criteria (Yes/No) at various timepoints up to month 12 follow up visit. | Day -59 to Month 12 |
| Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA) | Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit. A total score can fall between 0.0 and 3.0, with a higher score representing a more significant degree of disease activity. | Day -59 to Month 12 |