Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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

NCT06154252 · View on ClinicalTrials.gov ↗

Study Summary

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

Interventions

  • BIOLOGICAL CABA-201 following preconditioning with fludarabine and cyclophosphamide

Study Locations (20)

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients — Chicago
  • Northwestern Memorial Hospital - Accepting Adult Patients — Chicago
  • The University of Chicago Medical Center - Accepting Adult and Juvenile Patients — Chicago

New York

  • Hospital for Special Surgery - Accepting Adult and Juvenile Patients — New York
  • Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients — New York
  • Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients — The Bronx

California

  • University of California Irvine - Accepting Adult Patients — Orange
  • University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients — San Francisco

Florida

  • Mayo Clinic Florida - Accepting Adult Patients — Jacksonville
  • Johns Hopkins All Children's Hospital - Accepting Juvenile Patients — St. Petersburg

Georgia

  • Children's Healthcare of Atlanta - Accepting Juvenile Patients — Atlanta
  • Emory University - Accepting Adult Patients — Atlanta

North Carolina

  • University of North Carolina at Chapel Hill - Accepting Adult Patients — Chapel Hill
  • Duke University Medical Center - Accepting Young Adults and Juvenile Patients — Durham

Colorado

  • Children's Hospital Colorado - Accepting Juvenile Patients — Aurora

Kansas

  • University of Kansas Medical Center - Accepting Adult Patients — Kansas City

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2023-12-20
Est. Completion 2028-07
Phase Phase 2

Sponsor

Cabaletta Bio

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06154252

The ClinicalTrials.gov registry entry for NCT06154252 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cabaletta Bio, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 1 intervention — of which CABA-201 following preconditioning with fludarabine and cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06154252 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Illinois, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06154252 about?

NCT06154252 is a clinical study titled "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". 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

What is the current status of trial NCT06154252?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2023-12-20. Estimated completion is 2028-07.

What conditions does trial NCT06154252 study?

This clinical trial studies the following conditions: Dermatomyositis, Juvenile Dermatomyositis, Idiopathic Inflammatory Myopathy, Immune-Mediated Necrotizing Myopathy, Juvenile Polymyositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06154252?

The interventions under investigation include: CABA-201 following preconditioning with fludarabine and cyclophosphamide (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06154252?

This trial is sponsored by Cabaletta Bio, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06154252 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial