eligibility_summary
Eligible: protocol-defined, incurable locally advanced/metastatic cancer, ECOG 0–1, measurable disease (RECIST v1.1) within 28 days, life expectancy ≥3 mo, contraception per local rules, prior therapy per tumor type. Exclude: pregnancy/breastfeeding, inadequate organs, significant CV disease, CNS malignancy or non-malignant CNS disease/meds ≤2 yrs, active infection, prior CAR‑T/cellular/iPSC, ILD/pneumonitis, severe prior immune AEs, autoimmune/immune deficiency, organ allograft.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 trial of FT825/ONO-8250, an off-the-shelf, allogeneic iPSC-derived HER2 CAR-T cell therapy, given alone (Regimen A) or with cetuximab (Regimen B) after chemotherapy in advanced solid tumors. Mechanisms/types: FT825 (cell therapy) uses a HER2-specific CAR to trigger T-cell cytotoxicity against HER2 (ERBB2)-expressing tumor cells. Cetuximab (chimeric IgG1 monoclonal antibody) targets EGFR (ERBB1), blocks EGFR signaling, and induces ADCC, Regimen B enrolls EGFR-expressing tumors. Conditioning/chemo: fludarabine (antimetabolite lymphodepleter), cyclophosphamide or bendamustine (alkylating agents), plus docetaxel (taxane, microtubule stabilizer) or cisplatin (platinum, DNA crosslinker) to reduce tumor/enable CAR-T expansion. Targets/pathways: HER2 and EGFR on tumor cells, host lymphocyte depletion to support CAR-T engraftment.