CABA-201 for Myasthenia Gravis

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Cabaletta Bio

Disqualifiers: Severe infections, Cardiac impairment, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Eligibility Criteria

This trial is for adults aged 18 to 70 with Generalized Myasthenia Gravis (MG), a condition causing muscle weakness. Participants must have been diagnosed as seropositive or seronegative MG and exhibit certain levels of muscle weakness, according to the MGFA classification.

Inclusion Criteria

I am between 18 and 70 years old.

I have been diagnosed with Myasthenia Gravis and experience widespread muscle weakness.

I have been diagnosed with myasthenia gravis.

Exclusion Criteria

I have had a transplant of a solid organ or bone marrow.

History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites

I am currently being treated for an infection.

+4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of CABA-201 in combination with cyclophosphamide and fludarabine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and pharmacodynamics

28 days

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for long-term safety and efficacy, including evaluation of disease-related biomarkers and efficacy scores

156 weeks

Participant Groups

The study is testing CABA-201, a new potential treatment for Generalized Myasthenia Gravis. It's an open-label trial, meaning both researchers and participants know what treatment is being given, aimed at assessing how safe and effective this medication is.

1Treatment groups

Experimental Treatment

Group I: CABA-201Experimental Treatment1 Intervention

AChR Antibody-Positive Cohort AChR Antibody-Negative Cohort

CABA-201 is already approved in United States for the following indications:

🇺🇸 Approved in United States as CABA-201 for: