Trial NCT06359041
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
- Phase
- Phase 1/2
- Sponsor
- Cabaletta Bio
- Conditions
- Generalized Myasthenia Gravis (gMG)
- Ages
- 18–70 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Age ≥18 and ≤70 years of ageAge
* 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.Hepatic · Renal
* 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 impairmentCardiac
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
Other protocol-defined inclusion/exclusion criteria may apply.
Restrictions found (4)
- AgeConditionalinclusion
age <= 70
Show in the text - CardiacConditionalexclusionShow in the text
- HepaticConditionalexclusionShow in the text
- RenalConditionalexclusionShow in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- University of Massachusetts Chan Medical School · Worcester, Worcester County