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

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NCT06154252 · readout ≤ 711 d

Sponsored by Cabaletta Bio (industry) · CABA — their whole pipeline →.

Phase

Phase 2/3

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

74estimated

Sites

Countries

United Kingdom, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-12-20

actual

When the study began enrolling

Primary completion

Jul 2028

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jul 2028

estimated

The whole study's end, after follow-up

First posted

2023-12-04

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-23

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Intervention

Biological: CABA-201 following preconditioning with fludarabine and cyclophosphamide — also filed as Rese-cel, Resecabtagene autoleucel

Primary outcomes

what the primary-completion date above is the date OF

Phase 1/2: Incidence and severity of adverse events (AEs)

measured 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

measured 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

measured Within 24 weeks

Publications

PMID 39245937 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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