eligibility_summary
Eligibility: HER2+ recurrent/metastatic solid tumor (IHC 3+ or 2+ with ISH), no curative options, after ≥2 prior lines (breast/GE: ≥2 approved anti‑HER2, others: ≥2 SOC). Measurable disease, ECOG 0–1, adequate hepatic/cardiac function, O2>85%, biopsy consent, contraception. Exclude: pregnancy/lactation, HIV/HBV/HCV, immunosuppression, uncontrolled illness/infection, active CNS mets, unstable arrhythmias, other recent cancers, allergies to G‑CSF/excipients, concurrent therapy/other trials, required washouts.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CT-0525, an autologous, gene-modified cellular immunotherapy composed of peripheral blood monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR), given as a single IV infusion (3 or 10 billion CAR+ cells). Mechanism of action: CAR recognition of HER2 (ERBB2) on tumor cells activates monocytes that traffic to tumors, differentiate into macrophages, and eliminate HER2+ cells via phagocytosis/cytotoxic effector functions, while presenting tumor antigens and modulating the tumor microenvironment. Targets: HER2-overexpressing solid tumor cells and the innate myeloid pathway (monocyte/macrophage activation, phagocytosis, antigen presentation), with potential secondary activation of adaptive immunity. Phase 1, first-in-human safety/tolerability study.