CABA-201 for Inflammatory Myopathies

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Cabaletta Bio

Disqualifiers: Severe infections, Organ transplant, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Will I have to stop taking my current medications?

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

Eligibility Criteria

This trial is for adults aged 18-65 with active idiopathic inflammatory myopathy (IIM), including conditions like dermatomyositis and antisynthetase syndrome. Participants must have evidence of ongoing disease despite treatment, shown by muscle weakness or tests like MRI. Excluded are those with severe reactions to the study drugs, active infections needing treatment, major organ issues, previous CAR T cell therapy, or any transplants.

Inclusion Criteria

I experience muscle weakness.

I am between 18 and 65 years old.

My condition is active despite treatment, shown by tests like MRI or high CK levels.

+2 more

Exclusion Criteria

I am currently being treated for an infection.

I cannot undergo leukapheresis due to health reasons.

I have received CAR T cell therapy before.

+5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

Participants receive preconditioning with fludarabine and cyclophosphamide

1 week

Treatment

Participants receive a single infusion of CABA-201

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

156 weeks

Participant Groups

The trial is testing CABA-201 after patients receive fludarabine and cyclophosphamide preconditioning. It's an open-label study which means everyone knows they're getting the experimental treatment and there's no placebo group.

1Treatment groups

Experimental Treatment

Group I: CABA-201Experimental Treatment1 Intervention

DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with DM. ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with ASyS. IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with IMNM. JIIM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with JIIM.

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

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