Recruiting
Phase 1
Phase 2

CABA-201

Sponsor:

Cabaletta Bio

Code:

NCT06359041

Conditions

Generalized Myasthenia Gravis (gMG)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

CABA-201

CABA-201

Study Details

Brief 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

Conditions

Generalized Myasthenia Gravis (gMG)

Study ID

NCT06359041

Start date

Dec 17, 2024

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CABA-201

AChR Antibody-Positive Cohort or AChR Antibody-Negative Cohort

experimental: CABA-201, No Preconditioning

Infusion of CABA-201 with no preconditioning in subjects with gMG

Interventions

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

Primary outcome measure

  • To evaluate incidence and severity of adverse events (AEs) [ Time Frame: Up to 28 days after CABA-201 infusion ]

Central Contacts and Locations

Central contacts

Cabaletta Bio

267 759 3100clinicaltrials@cabalettabio.com

Locations

University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Alpha Clinic

949-824-3990alphaclinic@uci.edu

Principal Investigator:

Ali Habib, MD

UC Davis, Department of Neurology

Recruiting

Sacramento, California, United States, 95817

Contacts

Sahar Jammal

916-734-1798sjammal@ucdavis.edu

Principal Investigator:

David Richman, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Zane Ashkar

415-501-0671Zane.Ashkar@ucsf.edu

Principal Investigator:

Dr. Min Kang, MD

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Recruitment Specialist

303-724-4644neuroresearch@cuanschutz.edu

Alyssa Alviez

Alyssa.avilez@cuanschutz.edu

Principal Investigator:

Amanda Piquet, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Huy Tran CRC

904-953-4503Tran.Huy1@mayo.edu

Principal Investigator:

Dr. Jaimin Shah, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kaitlin King

312-921-2371Kaitlin.King@nm.org

Principal Investigator:

Dr. Arjun Seth, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Lilli Saavedra

913-945-9937lsaavedra2@kumc.edu

Principal Investigator:

Mazen Dimachkie, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Amy Lewandowski

617-667-2545alewand2@bidmc.harvard.edu

Principal Investigator:

Pushpa Narayanaswami, MD

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Catherine Douthwright

508-856-1524Catherine.Douthwright@umassmed.edu

Principal Investigator:

Dr. Margaret A. Owegi, DO

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Bridget Neja

507-266-9150neja.bridget@mayo.edu

Principal Investigator:

Elie Naddaf, M.D.

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

CPDM Nursing Navigator

212-342-5162cpdm_celltherapy@lists.cumc.columbia.edu

Principal Investigator:

Dr. Christina Ulane, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Olivia Tauriello

585-275-3707Olivia_Tauriello@URMC.Rochester.edu

Principal Investigator:

Dr. Alexis Lizarraga, MD, MS

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Katie Lewis

503-494-7394lewiskat@ohsu.edu

Principal Investigator:

Dr. Nizar Chahin, M.D.

Baylor College of Medicine Neurology Department

Recruiting

Houston, Texas, United States, 77030

Contacts

Victoria Herrick

713-798-5670victoria.herrick@bcm.edu

Principal Investigator:

Milvia Pleitez, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Delrose A Vernon, BS, MBA, CCRP

346-238-8226davernon@houstonmethodist.org

Principal Investigator:

Dr. Sheetal Shroff, MD

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Meredith del Rosario

713-792-1416mcdel@mdanderson.org

Principal Investigator:

Uday Popat, MD

Swedish Neuroscience Research

Recruiting

Seattle, Washington, United States, 98122

Contacts

Desiree Iriarte

206-320-2282desiree.iriarte@swedish.org

Mark Loreen

mark.loreen@swedish.org

Principal Investigator:

Dr. Christyn Edmundson, MD

More Information

Sponsor

Cabaletta Bio

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • CABA-201
  • autoimmune disease
  • anti-CD19 CAR-T therapy
  • cellular therapy
  • Myasthenia Gravis
  • Neuromuscular
  • Anti-AChR
  • Anti-LRP4
  • Anti-MuSK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cabaletta Bio on 2026-08-13.