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Monoclonal Antibodies

CABA-201 for Inflammatory Myopathies

Phase 1 & 2

Recruiting

Research Sponsored by Cabaletta Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of muscle weakness

Age ≥18 and ≤65

Must not have

Active infection requiring medical intervention at screening

Contraindication to leukapheresis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after caba-201 infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an experimental drug to see if it is safe and effective for treating patients with myopathy, an inflammation of the muscles.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, complications from leukapheresis (a procedure to collect white blood cells), and risks associated with chemotherapy agents used in preconditioning like nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience muscle weakness.

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I am between 18 and 65 years old.

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

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I have been diagnosed with a muscle condition due to specific antibodies in my blood.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for an infection.

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I cannot undergo leukapheresis due to health reasons.

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I have received CAR T cell therapy before.

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I do not have severe or worsening kidney, liver, blood, stomach, lung, mental health, heart, nerve, or brain diseases.

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I have serious heart or lung problems.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after caba-201 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after caba-201 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after caba-201 infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate adverse events reported by subjects

Secondary study objectives

To characterize the pharmacodynamics (PD)

To characterize the pharmacokinetics (PK)

To evaluate adverse events and laboratory abnormalities

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 10Eligibility criteria met