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NCT06154252RECRUITINGanonymous

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Sponsor

Source record

Cabaletta Bio

Phase

Source record

Phase 1/2

Modality

AI-normalized

protein therapy

Target

AI-normalized

CD19-specific Chimeric Antigen Receptor T Cells (CABA-201)

Indication / condition

AI-normalized

Idiopathic Inflammatory Myopathy

Intervention

Source record

CABA-201 following preconditioning with fludarabine and cyclophosphamide

Source & freshness

Source record

NCT ID

NCT06154252

Original source

ClinicalTrials.gov

Source last updated

Jun 10, 2026

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT06154252

Title

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Sponsor

Cabaletta Bio

Status

RECRUITING

Phase

Phase 1/2

Condition raw

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

Condition normalized

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

Modality raw

protein therapy

Modality normalized

protein therapy

Target raw

CD19-specific Chimeric Antigen Receptor T Cells (CABA-201)

Target normalized

CD19-specific Chimeric Antigen Receptor T Cells (CABA-201)

Interventions

CABA-201 following preconditioning with fludarabine and cyclophosphamide

Public preview

Source record

Cabaletta Bio's CABA-201 is positioned to address a significant unmet need in the treatment of Idiopathic Inflammatory Myopathy (IIM), including its juvenile form. The market for IIM therapies is currently underserved, with limited effective options available. The successful development of CABA-201 could provide a first-in-class treatment, potentially capturing a substantial share of the market. Given the increasing prevalence of autoimmune diseases and the growing interest in CAR T-cell therapies, this asset may attract significant attention from investors and partners. Competitive analysis indicates that while there are existing therapies for IIM, none specifically target the underlying mechanisms of disease as CABA-201 aims to do, positioning it favorably against current treatments.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT06154252

Status

RECRUITING

Phase

Phase 1/2

Sponsor

Cabaletta Bio

Executive brief

Investment-Ready Snapshot

Cabaletta Bio's CABA-201 is positioned to address a significant unmet need in the treatment of Idiopathic Inflammatory Myopathy (IIM), including its juvenile form. The market for IIM therapies is currently underserved, with limited effective options available. The successful development of CABA-201 could provide a first-in-class treatment, potentially capturing a substantial share of the market. Given the increasing prevalence of autoimmune diseases and the growing interest in CAR T-cell therapies, this asset may attract significant attention from investors and partners. Competitive analysis indicates that while there are existing therapies for IIM, none specifically target the underlying mechanisms of disease as CABA-201 aims to do, positioning it favorably against current treatments.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedJun 10, 2026
Internal syncJun 12, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06154252

Indication

Idiopathic Inflammatory Myopathy

Modality

protein therapy

Target

CD19-specific Chimeric Antigen Receptor T Cells (CABA-201)

Intervention

CABA-201 following preconditioning with fludarabine and cyclophosphamide

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.