Trial · NCT06154252
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1/2: Incidence and severity of adverse events (AEs) | Up to 28 days after CABA-201 infusion | Incidence and severity of AEs |
| Primary | 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 | Within 16 weeks | ≥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 |
| Primary | 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 | Within 24 weeks | ≥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 |
| Secondary | Incidence of adverse events and laboratory abnormalities | Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2) | Incidence and severity of AEs, including changes in laboratory values and vital signs |
| Secondary | Pharmacodynamics (PD) | Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2) | Levels of B cells in the blood |
| Secondary | Pharmacokinetics (PK) | Up to 156 weeks (Phase 1/2) and through 52 weeks (Sub-study 1 and 2) | Levels of CABA-201-positive T cells in the blood |
| Secondary | Change in disease-related biomarkers of muscle inflammation | Up to 156 weeks (Phase 1/2) | Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum |
| Secondary | Change in autoantibody-related biomarkers | Up to 156 weeks (Phase 1/2) | Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum |
| Secondary | Proportion of DM subjects achieving at least a moderate TIS without any immunomodulatory medications and no or low dose of steroids | Week 16 (Sub-study 1) | ≥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 |
| Secondary | 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 | Week 16 (Sub-study 1) | MMT-8 measures muscle strength on a scale ranging from 0 to 150 points, where higher scores reflect greater muscle strength |
| Secondary | Proportion of DM and ASyS subjects achieving a major TIS response without any immunomodulatory medications and no or low dose of steroids | Week 16 (Sub-study 1) | ≥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 |
| Secondary | Proportion of subjects with DM & ASyS achieving moderate TIS without any immunomodulatory medications on no or low dose of steroids | Week 52 (Sub-study 1) | ≥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 |
| Secondary | Proportion of subjects with DM achieving moderate TIS without any immunomodulatory medications on no or low dose of steroids | Week 52 (Sub-study 1) | ≥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 |
| Secondary | Mean change from baseline on the MMT-8 in subjects with IMNM without any immunomodulatory medications and no or low dose of steroids | Week 24 (Sub-study 2) | MMT-8 measures muscle strength on a scale ranging from 0 to 150 points, where higher scores reflect greater muscle strength |
| Secondary | Proportion of subjects with IMNM achieving at least minimal TIS response without immunomodulatory medications and no or low dose of steroids | Week 52 (Sub-study 2) | ≥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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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