eligibility_summary
Adults 25–72 with refractory dermatomyositis (EULAR/ACR, failed steroids and ≥2 IS), moderate–severe disease (MMT‑8<142 or CDASI‑a≥19) plus ≥2 IMACS CSMs, if using MMT‑8, must show active myositis (enzymes ≥2×ULN or recent MRI/EMG). ECOG 0–1, adequate organ function, vaccinated, contraception required. Exclude severe muscle damage, MDA5 RP‑ILD/major ILD or PH, other myopathies, prior CAR‑T/HSCT, active infections/immunodeficiency, neuro/cardiac disease, malignancy, hypersensitivity, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b, open-label study in refractory dermatomyositis testing KYV-101, an autologous, fully human anti-CD19 CAR T-cell therapy (cellular gene therapy/immunotherapy). Mechanism: patient T cells are engineered to express a chimeric antigen receptor that recognizes CD19, enabling cytotoxic killing of CD19+ B-lineage cells (naive/memory B cells and plasmablasts), aiming to deplete autoantibody-producing cells and reset humoral immunity. Lymphodepleting conditioning precedes infusion: cyclophosphamide (alkylating cytotoxic agent) and fludarabine (purine analog) to reduce host lymphocytes and support CAR T expansion, cohorts may de-escalate conditioning intensity. Targets: CD19 on B cells, pathways: B-cell/autoantibody axis driving skin, muscle, and lung inflammation.