NCT06913608WithdrawnPhase 1
A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases
A Phase lb Open-Label Study Evaluating the Safety and Efficacy of the Combination of CLBR00l, an Engineered Autologous T Cell Product, and SWI019, a CD19-directed Antibody-based Biologic With or Without Lymphodepletion in Subjects With Autoimmune Disorders Including Systemic Lupus Erythematosus, Systemic Sclerosis, or Idiopathic Inflammatory Myositis
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 28 Mar 2025
- Start date
- Mar 2026
- Primary completion date
- 3 Mar 2026
- Lead sponsor
- Calibr, a division of Scripps Research
- NCT number
- NCT06913608
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to tolerate washout of prior therapy.
- Have received plasmapheresis within 14 days prior to informed consent.
- 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
Other illness
- Known hypersensitivity to prednisone or to both tocilizumab siltuximab.
- Active bacterial, viral and/or fungal infection.
- HIV-1 and HIV-2 antibody positive subjects.
- History of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).
Other
- Not willing/understanding the requirements of the clinical study
- Dependent on hemodialysis for a period of greater or equal to 3 months.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.