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RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

RecruitingPhase 1/2

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

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 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
* Significant lung or cardiac impairment
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

Other protocol-defined inclusion/exclusion criteria may apply.

About the study

RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis

What is being tested

Sponsor: Cabaletta Bio · Participants: 24 · Started: Dec 17, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06359041

Locations in the U.S.

CaliforniaUniversity of California Irvine, Orange
UC Davis, Department of Neurology, Sacramento
University of California, San Francisco, San Francisco
ColoradoUniversity of Colorado, Aurora
FloridaMayo Clinic Florida, Jacksonville
IllinoisNorthwestern Memorial Hospital, Chicago
KansasUniversity of Kansas Medical Center, Kansas City
MassachusettsBeth Israel Deaconess Medical Center, Boston
University of Massachusetts Chan Medical School, Worcester
MinnesotaMayo Clinic - Rochester, Rochester
New YorkColumbia University, New York
University of Rochester Medical Center, Rochester
OregonOregon Health & Science University, Portland
TexasBaylor College of Medicine Neurology Department, Houston
Houston Methodist Hospital, Houston
University of Texas MD Anderson Cancer Center, Houston
WashingtonSwedish Neuroscience Research, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.