Evaluating CABA-201 for treating active systemic lupus erythematosus
A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus
This study is testing a new cell therapy called CABA-201 to see if it can help people with active lupus and kidney issues feel better and protect their organs.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cabaletta Bio Industry-sponsored |
| Drugs / interventions | CAR T, cyclophosphamide, fludarabine |
| Locations | 23 sites (Orange, California and 22 other locations) |
| Trial ID | NCT06121297 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of CABA-201, an investigational cell therapy, in patients with active systemic lupus erythematosus (SLE) and lupus nephritis (LN). Participants will be divided into two cohorts based on their condition, receiving a single dose of CABA-201 after being pretreated with standard medications, cyclophosphamide and fludarabine. The study aims to assess the therapeutic potential of this novel treatment in managing SLE symptoms and preventing organ damage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a clinical diagnosis of active systemic lupus erythematosus or biopsy-proven lupus nephritis.
Not a fit: Patients with contraindications to leukapheresis or severe uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with active systemic lupus erythematosus and lupus nephritis.
How similar studies have performed: Other studies have explored CAR-T therapies for autoimmune diseases, showing promising results, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 and ≤65 * A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE. * Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening. * For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria * For non-renal SLE subjects only: Active, moderate to severe SLE Exclusion Criteria: * Contraindication to leukapheresis * History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites * Active infection requiring medical intervention at screening * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections. * Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures * For LN subjects only: The presence of kidney disease other than active lupus nephritis * Previous CAR T cell therapy * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
Where this trial is running
Orange, California and 22 other locations
- University of California Irvine — Orange, California, United States (Recruiting)
- UC Davis Health — Sacramento, California, United States (Recruiting)
- Yale University — New Haven, Connecticut, United States (Recruiting)
- University of Florida Health — Gainesville, Florida, United States (Active_not_recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- UMass Memorial Hospital — Worcester, Massachusetts, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Withdrawn)
- University of Rochester — Rochester, New York, United States (Recruiting)
- UNC Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Maisonneuve-Rosemont Hospital — Montreal, Quebec, Canada (Recruiting)
- Clinica Universitaria de Navarra — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Study coordinator: Cabaletta Bio
- Email: clinicaltrials@cabalettabio.com
- Phone: 267 759 3100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.