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Business Decision
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The goal of this clinical trial is to evaluate CLBR001 and SWI019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis. Patients will be randomized 1:1 lymphodepletion vs no lymphodepletion arm. Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019 with regular assessments of safety and disease response to treatment.
The goals are to establish the safety and efficacy of the combination therapy and determine if lymphodepletion is required for efficacy.
CLBR001 + SWI019 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR (chimeric antigen receptor)-T product (CLBR001, the switchable CAR-T cell [sCAR-T]) and SWI019 (the "switch" biologic molecule). SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLBR001 + SWI019 following Lymphodepletion | Experimental | Subjects who are randomized into the lymphodepletion arm will undergo 3 days of lymphodepletion conditioning therapy consisting of fludarabine and cyclophosphamide prior to treatment with CLBR001+SWI019. |
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| CLBR001 + SWI019 without Lymphodepletion | Experimental | Subjects who are randomized into the NO lymphodepletion arm will receive treatment with CLBR001+SWI019 without lymphodepletion administered prior. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLBR001 + SWI019 | Combination Product | Investigational switchable CAR-T cell therapy for autoimmune disorders |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | To assess the safety and tolerability in subjects by evaluating the frequency, relatedness, severity and duration of adverse events (assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with exception of Cytokine Release Syndrome (CRS) or Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria). | To 1 year post CLBR001 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of CLBR001 + SWI019 in autoimmune disease | Efficacy will be measured by the number of subjects with a clinical response. | 1 year post CLBR001 administration |
| Quantification of white blood cells (WBCs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Calibr CMO | Calibr-Skaggs, Institute of Innovative Medicines | Study Director |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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Quantify WBCs, i.e. monocytes, neutrophils, other granulocytes, and lymphocytes, in peripheral blood to evaluate changes in circulating WBCs between subjects assigned to lymphodepletion vs no lymphodepletion arms to determine role of lymphodepletion in CAR-T cell engraftment.
| 1 year post CLBR001 administration |
| Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Maximum Concentration (Cmax) | Quantitation and persistence of CLBR001 cells in peripheral blood and PK parameters of SWI019 | 1 year post CLBR001 administration |
| Assess immunogenicity of CLBR001 and SWI019 | Immunogenic response to CLBR001 and SWI019 will be measured by presence of antidrug antibodies (ADA). | 1 year post CLBR001 administration |
| Number of subjects with Clinical Response | Evaluate anti-disease activity of CLBR001 and SWI019 by number of subjects with Clinical Response to treatment. | 1 year post CLBR001 administration |
| Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Time to Peak Drug Concentration (Tmax) | Quantitation and persistence of CLBR001 cells in peripheral blood and PK parameters of SWI019 | 1 year post CLBR001 administration |
| Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Area Under the Curve (AUC) | Quantitation and persistence of CLBR001 cells in peripheral blood and PK parameters of SWI019 | 1 year post CLBR001 administration |
| Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Half-life (t1/2) | Quantitation and persistence of CLBR001 cells in peripheral blood and PK parameters of SWI019 | 1 year post CLBR001 administration |
| D012871 | Skin Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |