A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases

NCT06913608 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: CBR-sCAR19-3003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Systemic Sclerosis (SSc); Idiopathic Inflammatory Myopathy (IIM); Systemic Lupus Erythematosus (SLE)

Keywords

CAR-T; systemic lupus erythematosus; systemic sclerosis; idiopathic inflammatory myopathy; SLE; IIM; SSc; cell therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Evaluate the efficacy of CLBR001 + SWI019 in autoimmune disease

  1 year post CLBR001 administration

• Quantification of white blood cells (WBCs)

  1 year post CLBR001 administration

• Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Maximum Concentration (Cmax)

  1 year post CLBR001 administration

• Assess immunogenicity of CLBR001 and SWI019

  1 year post CLBR001 administration

• Number of subjects with Clinical Response

  1 year post CLBR001 administration

Study Arms (2)

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.

Combination Product: CLBR001 + SWI019

CLBR001 + SWI019 without Lymphodepletion

EXPERIMENTAL

Subjects who are randomized into the NO lymphodepletion arm will receive treatment with CLBR001+SWI019 without lymphodepletion administered prior.

Combination Product: CLBR001 + SWI019

Interventions

CLBR001 + SWI019 COMBINATION_PRODUCT

Investigational switchable CAR-T cell therapy for autoimmune disorders

CLBR001 + SWI019 following Lymphodepletion; CLBR001 + SWI019 without Lymphodepletion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or men age ≥18 of age at time of consent.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of this study.
• Adequate hematological, liver, pulmonary, and cardiac function
• Willing to participate to participate in long term follow up study.
• Confirmed diagnosis of moderate to severe systemic lupus erythematosus with lupus nephritis, systemic lupus erythematosus with extrarenal lupus, systemic sclerosis, and idiopathic inflammatory myositis.
• Failed at least two immunosuppressive treatments

You may not qualify if:

• Inability to tolerate washout of prior therapy.
• Not willing/understanding the requirements of the clinical study
• Dependent on hemodialysis for a period of greater or equal to 3 months.
• Known hypersensitivity to prednisone or to both tocilizumab siltuximab.
• Have received plasmapheresis within 14 days prior to informed consent.
• Active bacterial, viral and/or fungal infection.
• Prior autologous/allogeneic stem cell transplant or solid organ transplant.
• Prior lentiviral or retroviral based therapy including CAR-T cell therapy.
• History or concurrent malignancy with active treatment in the past 5 years
• HIV-1 and HIV-2 antibody positive subjects.
• History of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).

Sponsors & Collaborators

• Calibr, a division of Scripps Research: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic; Myositis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Calibr CMO

  Calibr-Skaggs, Institute of Innovative Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 6, 2025
• Study Start: March 1, 2026
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share