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

Overview

About this study

The purpose of this study is to evaluate the safety and efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/05/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elie Naddaf, M.D.

Open for enrollment

Contact information:

Isabelle Meunier

(507) 538-6337

Meunier.Isabelle@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Jaimin Shah, M.D.

Contact us for the latest status

Contact information:

Jeffery Gainer C.C.R.C.

Gainer.Jeffery@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20580814

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