Systemic Lupus Erythematosus (SLE)Phase 1NCT06913608
A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases
A Phase 1 study testing CLBR001 + SWI019 in people with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), run by Calibr, a division of Scripps Research.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
- What is being tested?
- CLBR001 + SWI019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to 3 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
- Being tested
- CLBR001 + SWI019
- Keywords
- CAR-T, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, SLE, IIM, SSc, cell therapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLBR001 + SWI019Combination product
Investigational switchable CAR-T cell therapy for autoimmune disorders
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: CLBR001 + SWI019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: To 1 year post CLBR001 administration
Secondary outcomes (8)
Evaluate the efficacy of CLBR001 + SWI019 in autoimmune disease
Efficacy will be measured by the number of subjects with a clinical response.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year post CLBR001 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study startMar 2026 (estimated)
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibr, a division of Scripps Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Calibr CMO, Study director, Calibr-Skaggs, Institute of Innovative Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913608
- Sponsor's protocol ID
- CBR-sCAR19-3003
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06913608
- Acronym / sponsor ID
- CBR-sCAR19-3003
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM)
- Keywords
- CAR-T, systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, SLE, IIM, SSc, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Calibr, a division of Scripps ResearchUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLBR001 + SWI019 following Lymphodepletion | Experimental | Combination Product: CLBR001 + SWI019Subjects 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. |
| CLBR001 + SWI019 without Lymphodepletion | Experimental | Combination Product: CLBR001 + SWI019Subjects who are randomized into the NO lymphodepletion arm will receive treatment with CLBR001+SWI019 without lymphodepletion administered prior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLBR001 + SWI019Investigational switchable CAR-T cell therapy for autoimmune disorders | Combination product | CLBR001 + SWI019 following Lymphodepletion, CLBR001 + SWI019 without Lymphodepletion |
Primary outcome
Number of subjects with adverse events
Time frame: To 1 year post CLBR001 administration
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).
8 secondary outcomes
Evaluate the efficacy of CLBR001 + SWI019 in autoimmune disease
Time frame: 1 year post CLBR001 administration
Quantification of white blood cells (WBCs)
Time frame: 1 year post CLBR001 administration
Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Maximum Concentration (Cmax)
Time frame: 1 year post CLBR001 administration
Assess immunogenicity of CLBR001 and SWI019
Time frame: 1 year post CLBR001 administration
Number of subjects with Clinical Response
Time frame: 1 year post CLBR001 administration
Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Time to Peak Drug Concentration (Tmax)
Time frame: 1 year post CLBR001 administration
Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Area Under the Curve (AUC)
Time frame: 1 year post CLBR001 administration
Evaluate the pharmacokinetics (PK) of CLBR001 and SWI019: Half-life (t1/2)
Time frame: 1 year post CLBR001 administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calibr CMO study director
Calibr-Skaggs, Institute of Innovative Medicines
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLBR001 + SWI019 in people with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc), run by Calibr, a division of Scripps Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (time frame: To 1 year post CLBR001 administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.