TrialRESET-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
Trial details
- Registry ID
- NCT06154252
- Phase
- Phase 2, Phase 3
CABA
Cabaletta Bio
Company identity has not yet been verified
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2Trials in this database
6Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far
Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
Completion dates · Pro
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Pro summarizes how far estimated completion dates moved later and counts trials with edits to their main study measures, using the history available here. View Pro features
Included trials
Check company identity source| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| 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 MyopathyNCT06154252 | Cabaletta Bio | Phase 2, Phase 3 | Recruiting | 2028-07Estimated |
| RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic SclerosisNCT06328777 | Cabaletta Bio | Phase 2, Phase 3 | Recruiting | 2029-07Estimated |
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
Trial details
- Registry ID
- NCT06328777
- Phase
- Phase 2, Phase 3
Latest recorded trial changes
RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis
NCT06328777 · Cabaletta Bio
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: To evaluate incidence of adverse events
+ After
Measure: Phase 1/2: To evaluate incidence of adverse events Measure: Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjects
Planned enrollment increased by 25 participants
− Before
12 participants (planned)
+ After
37 participants (planned)
Phase changed
− Before
PHASE1, PHASE2
+ After
PHASE2, PHASE3
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 · Cabaletta Bio
Main study measure wording changed
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Compare wording
− Before
Measure: To evaluate adverse events reported by subjects
+ After
Measure: Phase 1/2: Incidence and severity of adverse events (AEs) Measure: 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 Measure: 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
Planned enrollment increased by 50 participants
− Before
24 participants (planned)
+ After
74 participants (planned)
Phase changed
− Before
PHASE1, PHASE2
+ After
PHASE2, PHASE3