A Phase 1 interventional study of CLBR001 + SWI019 in Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc) and Idiopathic Inflammatory Myopathy (IIM), sponsored by Calibr, a division of Scripps Research. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Calibr, a division of Scripps Research · Phase 1, Interventional, and Treatment
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →Calibr, a division of Scripps Research is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
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.
Combination Product: CLBR001 + SWI019
Subjects who are randomized into the NO lymphodepletion arm will receive treatment with CLBR001+SWI019 without lymphodepletion administered prior.
Combination Product: CLBR001 + SWI019
Investigational switchable CAR-T cell therapy for autoimmune disorders
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).
Time frame: To 1 year post CLBR001 administration
Evaluate the efficacy of CLBR001 + SWI019 in autoimmune disease
Efficacy will be measured by the number of subjects with a clinical response.
Time frame: 1 year post CLBR001 administration
Quantification of white blood cells (WBCs)
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.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year post CLBR001 administration
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Calibr, a division of Scripps Research