RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Part of paid clinical trials in Orange, California.
- Sponsor
- Cabaletta Bio
- Study ID
- NCT06121297
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- CABA-201 — BIOLOGICALSingle intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
- CABA-201 — BIOLOGICALSingle intravenous infusion of CABA-201 at escalating dose levels without preconditioning
Study Details
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Key Dates
- Start date
- Feb 16, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: CABA-201 with FLU/CY PreconditioningLN Cohort: Infusion of CABA-201 with preconditioning in subjects with LN Non-renal SLE Cohort: Infusion of CABA-201 with preconditioning in subjects with non-renal SLE who do not meet criteria for inclusion in the LN cohort Expansion Cohort: Infusion of CABA-201 with preconditioning in subjects with LN and SLE
- Experimental: CABA-201, No PreconditioningInfusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE
Primary Outcome Measure
To evaluate incidence of adverse events [ Time Frame: Up to 28 days after CABA-201 infusion ]
Central Contacts
- Cabaletta Bio267 759 3100
Locations (21)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | Priyanka Iyer, MD (PRINCIPAL_INVESTIGATOR) |
| UC Davis Health | Sacramento | California | 95817 | Gaurav Gulati, MD (PRINCIPAL_INVESTIGATOR) |
| Yale University | New Haven | Connecticut | 06520 | Fotios Koumpouras, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Florida Health | Gainesville | Florida | 32610 | - |
| Mayo Clinic | Jacksonville | Florida | 32224 | Vikas Majithia, MBBS, MPH (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30322 | Arezou Khosroshahi, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Irene Blanco, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | Dr. Cuoghi Edens, MD, FAAP (PRINCIPAL_INVESTIGATOR) |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Kimberly Liang, MD (PRINCIPAL_INVESTIGATOR) |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Susan Prockop, MD (PRINCIPAL_INVESTIGATOR) |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Elena Massarotti, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Meghan Sise, MD (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Andreas Klein, MD (PRINCIPAL_INVESTIGATOR) |
| UMass Memorial Hospital | Worcester | Massachusetts | 01655 | Roberto Caricchio, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55414 | Patrick Nachman, MD, FASN (PRINCIPAL_INVESTIGATOR) |
| Columbia University Irving Medical Center | New York | New York | 10032 | - |
| University of Rochester | Rochester | New York | 14642 | Christopher Palma, MD, ScM (PRINCIPAL_INVESTIGATOR) |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | Saira Sheikh, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Caitlin Elgarten (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Melissa Cunningham, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Biruh Workeneh, MD, FASN (PRINCIPAL_INVESTIGATOR) |
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