A Phase 2/3 interventional study of CABA-201 following preconditioning with fludarabine and cyclophosphamide in Idiopathic Inflammatory Myopathy, Dermatomyositis and Anti-Synthetase Syndrome, sponsored by Cabaletta Bio. Recruiting at 38 sites in 4 countries. Open to participants aged 6 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Cabaletta Bio · Phase 2/3, Interventional, and Treatment
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
Idiopathic inflammatory myopathies (IIMs, or myositis) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. Though the cause of IIM is not well understood, some subtypes of IIM, including dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM), and juvenile idiopathic inflammatory myopathy (JIIM), are thought to involve B cells that cause the body to attack different tissues in the body. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with DM, ASyS, IMNM, or JIIM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's planned enrollment of 74 is above the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis studies →Cabaletta Bio is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult Cohorts
Inclusion Criteria:
Other protocol-defined criteria apply.
Exclusion Criteria:
Other protocol-defined criteria apply.
Juvenile Cohort
Inclusion Criteria:
Other protocol-defined criteria apply.
Exclusion Criteria:
Other protocol-defined criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with DM. ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with ASyS. IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with IMNM. JIIM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with JIIM.
Biological: CABA-201 following preconditioning with fludarabine and cyclophosphamide
Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with DM and ASyS.
Biological: CABA-201 following preconditioning with fludarabine and cyclophosphamide
Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide in subjects with IMNM.
Biological: CABA-201 following preconditioning with fludarabine and cyclophosphamide
Drug page: Autologous Anti-CD19 CAR-T Cells CABA-201
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Also known as: Rese-cel, Resecabtagene autoleucel
Phase 1/2: Incidence and severity of adverse events (AEs)
Incidence and severity of AEs
Time frame: Up to 28 days after CABA-201 infusion
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 steroids
≥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
Time frame: Within 16 weeks
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 steroids
≥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
Time frame: Within 24 weeks
Incidence of adverse events and laboratory abnormalities
Incidence and severity of AEs, including changes in laboratory values and vital signs
Time frame: Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2)
Pharmacodynamics (PD)
Levels of B cells in the blood
Time frame: Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2)
Pharmacokinetics (PK)
Levels of CABA-201-positive T cells in the blood
Time frame: Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2)
Change in disease-related biomarkers of muscle inflammation
Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum
Time frame: Up to 156 weeks (Phase 1/2)
Change in autoantibody-related biomarkers
Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum
Time frame: Up to 156 weeks (Phase 1/2)
Proportion of DM subjects achieving at least a moderate TIS without any immunomodulatory medications and no or low dose of steroids
≥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
Time frame: Week 16 (Sub-study 1)
Mean change from baseline on the MMT-8 in subjects with DM and ASyS without any immunomodulatory medications and no or low dose of steroids
MMT-8 measures muscle strength on a scale ranging from 0 to 150 points, where higher scores reflect greater muscle strength
Time frame: Week 16 (Sub-study 1)
Proportion of DM and ASyS subjects achieving a major TIS response without any immunomodulatory medications and no or low dose of steroids
≥60 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement
Time frame: Week 16 (Sub-study 1)
Proportion of subjects with DM & ASyS achieving moderate TIS without any immunomodulatory medications on no or low dose of steroids
≥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
Time frame: Week 52 (Sub-study 1)
Proportion of subjects with DM achieving moderate TIS without any immunomodulatory medications on no or low dose of steroids
≥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
Time frame: Week 52 (Sub-study 1)
Mean change from baseline on the MMT-8 in subjects with IMNM without any immunomodulatory medications and no or low dose of steroids
MMT-8 measures muscle strength on a scale ranging from 0 to 150 points, where higher scores reflect greater muscle strength
Time frame: Week 24 (Sub-study 2)
Proportion of subjects with IMNM achieving at least minimal TIS response without immunomodulatory medications and no or low dose of steroids
≥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
Time frame: Week 52 (Sub-study 2)
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Autologous Anti-CD19 CAR-T Cells CABA-201
Cabaletta Bio