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NCT06154252 · ClinicalTrials.gov registry record · 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

A Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis, sponsored by Cabaletta Bio.

Recruiting
Registry status
Phase 2
Development phase
74
Enrollment target
20
Study locations

NCT06154252 is a Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis that is actively recruiting participants, run by Cabaletta Bio. The registered enrollment target is 74 participants, below the 481-participant average among 19 other Dermatomyositis trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06154252, a Phase 2 study of Dermatomyositis and Juvenile Dermatomyositis, is actively recruiting participants, sponsored by Cabaletta Bio.

RECRUITING
Registry status
Phase 2
Development phase
74 participants
Enrollment target
20
Study locations

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

6 total trials

What the Registry Record Tells You About NCT06154252

The ClinicalTrials.gov registry entry for NCT06154252 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 19 other Dermatomyositis trials with a reported enrollment target (85% lower). The listed sponsor is Cabaletta Bio, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT06154252 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Illinois, New York, California.

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, Anti-Synthetase Syndrome.

What interventions are being tested in trial NCT06154252?

The interventions under investigation include: CABA-201 following preconditioning with fludarabine and cyclophosphamide (BIOLOGICAL).

Who is sponsoring clinical trial NCT06154252?

This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.