eligibility_summary
Adults ≥18 with refractory idiopathic inflammatory myopathy, diffuse cutaneous systemic sclerosis (≤6 yrs), biopsy‑proven active class III/IV lupus nephritis, or GPA/MPA, meeting ACR/EULAR criteria, active disease and required serology (MSA except DM, PR3/MPO‑ANCA), ECOG 0–2, adequate organ function, contraception. Exclude severe/rapidly progressive organ damage, major cardiac/CNS disease, active infections, prior cell therapy, recent cancer, pregnancy, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
CARTIMMUNE (NCT06152172) tests KYV-101, an autologous, fully human anti-CD19 CAR T-cell therapy, as a single IV dose (1×10^8 CAR+ T cells) after lymphodepletion with cyclophosphamide (alkylating agent, DNA crosslinking) and fludarabine (purine analog, inhibits DNA synthesis) given IV daily ×3 to enhance CAR-T expansion/persistence. Mechanism: KYV-101 T cells recognize CD19 and eliminate CD19+ B cells/plasmablasts via T-cell cytotoxicity, inducing deep B-cell depletion and an immune “reset” to reduce pathogenic autoantibodies. Targets: the CD19+ B-cell compartment and humoral autoimmunity pathways (BCR signaling, autoantibody production) implicated in idiopathic inflammatory myopathies, diffuse cutaneous systemic sclerosis, SLE nephritis, and ANCA-associated vasculitis (e.g., ANCAs, anti-dsDNA, myositis-specific antibodies).