eligibility_summary
Include: TNBC or HER2+ breast cancer with confirmed LMD (CSF+ or MRI), ECOG ≤3, life expectancy ≥8 wks, stable CNS mets allowed, prior RT/SRS/surgery per washouts, adequate organs (recent labs), Ommaya/equivalent CSF access, steroids ≤8 mg dex. Exclude: recent LMD therapy or immunotherapy, live vaccine, major surgery/trauma, active infection, no contrast MRI, shunt lacking on/off or intolerant 4‑h closure, other active cancer, HIV/HBV/HCV, organ transplant, recent transfusion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05809752: Phase 1, single-arm, intrathecal dendritic cell vaccine (DC1) pulsed with HER2/HER3 peptides for leptomeningeal disease from TNBC or HER2+ breast cancer. Intervention type: biological, cellular immunotherapy. Dosing: weekly IT infusions via Ommaya, dose escalation 1, 2, 10, 50 million cells (6 doses/cycle, up to 2 cycles). Mechanism: DC1 act as professional antigen-presenting cells, presenting HER2/HER3 peptides to prime/activate tumor‑specific T cells (Th1/CTL) in CSF, promoting immune-mediated killing of cancer cells. Targets: tumor cells expressing HER2 and/or HER3 (ERBB2/ERBB3) signaling, immune axis involves dendritic cells and T‑cell activation in the leptomeninges. Primary aim: safety and dose finding.