eligibility_summary
Eligibility: Adults 18–75, >35 kg, consented, on stable immunosuppressive therapy ≥4 weeks for SLE, AAV, or IIM. SLE per 2019 EULAR/ACR or 2012 SLICC with ANA>1:80 or anti‑dsDNA, AAV per 2022 ACR/EULAR (MPA, GPA, EGPA), IIM: probable/definite dermatomyositis or IMNM. Exclude: major non‑target illness, rapidly progressive GN, active CNS lupus, significant neuro/cardiac disease, prior transplant or CAR‑T, drug‑induced disease, primary immunodeficiency.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests IMPT-514, an autologous anti-CD19/CD20 CAR T-cell therapy (genetically engineered cell therapy). Patients receive a single IV infusion after lymphodepleting chemotherapy (fludarabine + cyclophosphamide) to enable CAR T expansion. Mechanism: patient T cells are engineered to express a CAR that binds CD19 and CD20 on B-lineage cells, triggering targeted cytotoxic B-cell depletion. Dual CD19/CD20 targeting aims to enhance breadth and reduce antigen-escape. Targeted cells/pathways: CD19+ and CD20+ B cells (pre- and mature B cells, limited plasma cells), thereby suppressing autoantibody-producing pathways (e.g., anti-dsDNA, ANCA) and B cell–driven immune activation. Indications: refractory SLE, ANCA-associated vasculitis, and idiopathic inflammatory myopathy. Early Phase 1, single-arm.