Tests CABA-201 cell therapy in adults with generalized myasthenia gravis
Tests CABA-201, a cell therapy, in adults with generalized myasthenia gravis.
Plain-language title generated from the registry record
Registry title: RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Key facts
- Where
- Aurora, Boston, Chicago, Houston, Jacksonville, Kansas City, New York, Orange, Portland, Rochester, Sacramento, San Francisco, Seattle, and Worcester, United StatesSee the 17 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 18 and 70 years old?
Source: NCT06359041, who can take part
Where in United States
- University of ColoradoAurora, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- Baylor College of Medicine Neurology DepartmentHouston, United StatesTaking people
- Houston Methodist HospitalHouston, United StatesTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Columbia UniversityNew York, United StatesTaking people
- University of California IrvineOrange, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- University of Rochester Medical CenterRochester, United StatesTaking people
- UC Davis, Department of NeurologySacramento, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- Swedish Neuroscience ResearchSeattle, United StatesTaking people
- University of Massachusetts Chan Medical SchoolWorcester, 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
- NCT06359041
- Record updated
- 19 October 2026
- Original description
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia GravisRead full original descriptionShow less
RESET-MG: 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 Participants With Generalized Myasthenia Gravis
RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
Inclusion: Age ≥18 and ≤70 years of age; Diagnosis of MG with generalized muscle weakness meeting criteria as defined by the MGFA class II, III , IVa, and IVb; Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG.
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; Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant; Other protocol-defined inclusion/exclusion criteria may apply; 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; Significant lung or cardiac impairment; Contraindication to leukapheresis.