Status:
NOT_YET_RECRUITING
A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases
Lead Sponsor:
Calibr, a division of Scripps Research
Conditions:
Systemic Lupus Erythematosus (SLE)
Systemic Sclerosis (SSc)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 infl...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06913608
Start Date
February 1 2026
End Date
August 1 2028
Last Update
January 9 2026
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.