CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 (NCT06152172)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (83 items) and avoid the listed exclusions (52 items).
Location: Hospital of the Universithy of Pennsylvania — Philadelphia, Pennsylvania
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria Autoimmune Disease-Related Exclusion Criteria Idiopathic inflammatory myopathy: 1a. Evidence of any of the following:
- Severe muscle damage as per one of the following criteria:
- Myositis Global Damage Index (MDI) ≥5.
- Severe proximal muscle atrophy of upper or lower extremity on MRI.
- Severe proximal muscle atrophy of upper or lower extremity on clinical examination.
- Wheelchair-bound at home.
- MMT-8 of ≤80.
- MDA5-positive rapidly progressing disease (subjects with stable ILD not requiring supplemental oxygen are eligible).
- Findings of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), cancer-associated myositis (myositis diagnosed within 2 years of cancer), drug-induced myopathy, amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease (overlap myositis), except with Sjögren's syndrome.
- Patients with ILD requiring O2 therapy and/or FVC ≤45% of predicted.
- Generalized, severe musculoskeletal or neuro-muscular conditions other than IIM that prevent a sufficient assessment of the patient by the physician. Diffuse cutaneous systemic sclerosis:
- b. Subject with any of the following:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hospital of the Universithy of Pennsylvania — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.