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RESET-Myositis: CABA-201 for Idiopathic Inflammatory Myopathy

This study, called RESET-Myositis, is looking at a new cell therapy called CABA-201 for people with active idiopathic inflammatory myopathy (IIM), which includes conditions like dermatomyositis (DM), anti-synthetase syndrome (ASyS), and immune-mediated necrotizing myopathy (IMNM). IIMs are rare autoimmune diseases that cause inflammation and muscle weakness. This study aims to see how safe and effective CABA-201 is when given as a single infusion after you receive other medicines called fludarabine and cyclophosphamide. To join, you must be between 18 and 75 years old with an IIM diagnosis and active disease, even if you've had other treatments. The study will measure side effects and how many people improve without needing other medications or high doses of steroids.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 74 participants.
What's involved
You would receive a single intravenous infusion of CABA-201 after preconditioning with fludarabine and cyclophosphamide.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects for up to 28 days after the CABA-201 infusion, and measure improvement for up to 16 or 24 weeks depending on your specific condition.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06154252

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Recruiting
PHASE2Ages 6–75InterventionalTreatment
Cabaletta Bio
~74 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:CABA-201 following preconditioning with fludarabine and cyclophosphamide

At a glance

Recruiting sites
34 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1/2: Incidence and severity of adverse events (AEs)
Measured over Up to 28 days after CABA-201 infusion
+2 more outcomes measured

Conditions

Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
Juvenile Dermatomyositis
Juvenile Polymyositis
Juvenile Idiopathic Inflammatory Myopathy (JIIM)
Juvenile Myositis

Explore related trials

Anti-Synthetase SyndromeChildhood DermatomyositisDermatomyositisIdiopathic Inflammatory MyopathyImmune-Mediated Necrotizing MyopathyJuvenile Polymyositis

Where it's being run

35 sites across 20 states
United Kingdom4
Illinois3
New York3
Pennsylvania3
Texas3
California2
Florida2
Georgia2

Study leadership

  • Medical Director · STUDY_CHAIR · Cabaletta Bio

Who to contact

Cabaletta Bio
[email protected]
267-759-3100 · ext. 4444
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 and ≤75
A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
Diagnosis of DM, ASyS, or IMNM
Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
Presence of muscle weakness
Age ≥6 and ≤17 years at enrollment
A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography

Exclusion

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
Previous CAR T cell therapy
Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant
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
Previous CAR T cell therapy
Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

What this trial measures

  • Phase 1/2: Incidence and severity of adverse events (AEs)Up to 28 days after CABA-201 infusion

    Incidence and severity of AEs

  • Phase 2b Sub-study 1: Proportion of DM & ASyS subjects achieving at least a moderate Total Improvement Score (TIS) without any immunomodulatory medications and no or low dose of steroidsWithin 16 weeks

    ≥40 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement

  • Phase 2b Sub-study 2: Proportion of subjects with IMNM achieving at least a minimal TIS without any immunomodulatory medications and no or low dose of steroidsWithin 24 weeks

    ≥20 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement