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Recruiting Phase 1/2

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

NCT06359041 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2024-12-17
Last updated
2026-10-19

Condition(s) studied

Generalized Myasthenia Gravis (gMG)

Investigational drug(s) / intervention(s)

CABA-201 →CABA-201 →

CABA-201: Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

CABA-201: Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To evaluate incidence and severity of adverse events (AEs) — Up to 28 days after CABA-201 infusion
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal result of an investigation), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The term AE is used to include both serious and non-serious AEs.

Trial sites (17)

FacilityCityRegionStatus
University of California Irvine Orange California Recruiting
UC Davis, Department of Neurology Sacramento California Recruiting
University of California, San Francisco San Francisco California Recruiting
University of Colorado Aurora Colorado Recruiting
Mayo Clinic Florida Jacksonville Florida Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Columbia University New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Baylor College of Medicine Neurology Department Houston Texas Recruiting
Houston Methodist Hospital Houston Texas Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Swedish Neuroscience Research Seattle Washington Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06359041 on ClinicalTrials.gov ↗ ← All trials in the USA