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RecruitingPhase 1/Phase 2

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

Cabaletta Bio · NCT06359041

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
24
US sites recruiting
17
Study start
December 17, 2024
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: CABA-201; CABA-201

Conditions: Generalized Myasthenia Gravis (gMG)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of California Irvine

    Orange, CA 92868

    Site contact: Alpha Clinic · 949-824-3990 · alphaclinic@uci.edu

  • UC Davis, Department of Neurology

    Sacramento, CA 95817

    Site contact: Danielle Davis · 916-734-1798 · ddavis4@health.ucdavis.edu

  • University of California, San Francisco

    San Francisco, CA 94143

    Site contact: Zane Ashkar - Clinical Research Coordinator · 415-501-0671 · Zane.Ashkar@ucsf.edu

  • University of Colorado

    Aurora, CO 80045

    Site contact: Recruitment Specialist · 303-724-4644 · neuroresearch@cuanschutz.edu

  • Mayo Clinic Florida

    Jacksonville, FL 32224

    Site contact: Huy Tran CRC · 904-953-4503 · Tran.Huy1@mayo.edu

  • Northwestern Memorial Hospital

    Chicago, IL 60611

    Site contact: Kaitlin King · 312-921-2371 · Kaitlin.King@nm.org

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Lilli Saavedra · 913-945-9937 · lsaavedra2@kumc.edu

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Amy Lewandowski · 617-667-2545 · alewand2@bidmc.harvard.edu

  • University of Massachusetts Chan Medical School

    Worcester, MA 01655

    Site contact: Catherine Douthwright · 508-856-1524 · Catherine.Douthwright@umassmed.edu

  • Mayo Clinic - Rochester

    Rochester, MN 55905

    Site contact: Bridget Neja · 507-266-9150 · neja.bridget@mayo.edu

  • Columbia University

    New York, NY 10032

    Site contact: CPDM Nursing Navigator · 212-342-5162 · cpdm_celltherapy@lists.cumc.columbia.edu

  • University of Rochester Medical Center

    Rochester, NY 14642

    Site contact: Olivia Tauriello · 585-275-3707 · Olivia_Tauriello@URMC.Rochester.edu

  • Oregon Health & Science University

    Portland, OR 97239

    Site contact: Katie Lewis · 503-494-7394 · lewiskat@ohsu.edu

  • Baylor College of Medicine Neurology Department

    Houston, TX 77030

    Site contact: Robbie Henderson · 713-798-7486 · rlhender@bcm.edu

  • Houston Methodist Hospital

    Houston, TX 77030

    Site contact: Amelia Nounes · 346-356-3639 · aanounes@houstonmethodist.org

  • University of Texas MD Anderson Cancer Center

    Houston, TX 77030

    Site contact: Meredith del Rosario · 713-792-1416 · mcdel@mdanderson.org

  • Swedish Neuroscience Research

    Seattle, WA 98122

    Site contact: Desiree Iriarte · 206-320-2282 · desiree.iriarte@swedish.org

Study contacts (from the official record)

  • Cabaletta Bio · 267 759 3100 · clinicaltrials@cabalettabio.com
All phase 1 studies in California →
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201… (NCT06359041) | Bored Studies