eligibility_summary
Adults 18–75 with recurrent high‑grade serous/endometrioid ovarian/fallopian/peritoneal cancer, measurable disease, ≤4 prior regimens incl platinum/taxane, bevacizumab, PARP if BRCA. Require HLA‑A02+ (not 02:05), MAGE‑A4 ≥30% (≥2+), ECOG 0–1, LVEF ≥50%, adequate organs, fit for leukapheresis, contraception. Exclude: inadequate washouts, unresolved tox, recent major surgery, symptomatic CNS mets, significant cardiac/pulmonary disease, active HIV/HBV/HCV/HTLV, pregnancy, uncontrolled autoimmune, nivolumab allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, randomized (non-comparative) trial in recurrent ovarian cancer (HLA‑A2+, MAGE‑A4+). Interventions: 1) ADP‑A2M4CD8, an autologous genetically modified TCR‑engineered T‑cell (SPEAR) therapy expressing an affinity‑enhanced TCR for MAGE‑A4 peptide presented by HLA‑A2 and co‑expressing CD8αβ to augment class I–restricted cytotoxicity, 2) the same T cells plus nivolumab, a PD‑1–blocking human IgG4 monoclonal antibody checkpoint inhibitor. Mechanisms: engineered T cells recognize HLA‑A2/MAGE‑A4 on tumor cells to activate and kill, nivolumab relieves PD‑1 inhibition to boost T‑cell activity. Targets: MAGE‑A4–positive tumor cells, TCR/HLA‑I pathway, PD‑1/PD‑L1 checkpoint axis.