Tests CABA-201 cell therapy in people with active lupus
Tests CABA-201, a modified immune cell treatment, in people with active lupus.
Plain-language title generated from the registry record
Registry title: 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 facts
- Where
- Atlanta, Boston, Chapel Hill, Charleston, Chicago, Gainesville, Houston, Jacksonville, Kansas City, Minneapolis, New Haven, New York, Orange, Philadelphia, Rochester, Sacramento, and Worcester, United StatesSee the 21 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 65 years old?
Source: NCT06121297, who can take part
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- Boston Children's Hospital - Accepting Young Adult and Adolescent PatientsBoston, United StatesTaking people
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- UNC- Chapel HillChapel Hill, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- The University of Chicago Medical Center - Accepting Adult and Adolescent PatientsChicago, United StatesTaking people
- University of Florida HealthGainesville, United StatesNo longer taking part
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- Mayo ClinicJacksonville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- Yale UniversityNew Haven, United StatesNo longer taking part
- Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
- University of California IrvineOrange, United StatesTaking people
- Children's Hospital of Philadelphia - Accepting Young Adult and Adolescent PatientsPhiladelphia, United StatesTaking people
- University of RochesterRochester, United StatesTaking people
- UC Davis HealthSacramento, United StatesTaking people
- UMASS Memorial HospitalWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cabaletta Bio
- Trial code
- NCT06121297EU 2023-507613-10-01
- Record updated
- 6 October 2026
- Original description
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus ErythematosusRead full original descriptionShow less
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
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
Inclusion: Age ≥18 and ≤65 (Adults) or Age ≥12 to <18 years (Adolescents); A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for 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: 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; Previous CAR T cell therapy; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; 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; For LN subjects only: The presence of kidney disease other than active lupus nephritis; Contraindication to leukapheresis.