eligibility_summary
Eligibility: Unresectable/metastatic solid tumors after ≥2 prior regimens (≥1 targeted), measurable lesion (RECIST 1.1), ECOG 0–1, adequate hematologic/renal/hepatic/cardiac function, SpO2 ≥92% on room air. Exclude: prior EGFR gene‑modified cell therapy, allogeneic transplant, active CNS mets or major CNS disorder, significant active infection, HIV/HBV/HCV, other malignancies unless treated NED, primary immunodeficiency, pregnancy/lactation, or inability to comply/consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06415487: Phase 1 trial of ACE2016, an off‑the‑shelf allogeneic anti‑EGFR–conjugated gamma delta T‑cell (gdT) therapy, in EGFR-expressing advanced solid tumors, given alone or with pembrolizumab after lymphodepletion. Interventions and mechanisms: • ACE2016 (cell therapy): healthy‑donor gdT cells conjugated to an anti‑EGFR antibody to redirect gdT cytotoxicity toward EGFR+ tumor cells, kills via T‑cell effector functions. • Cyclophosphamide (alkylating chemotherapy) and fludarabine (purine analog): lymphodepleting drugs that reduce host lymphocytes to enable ACE2016 persistence/expansion. • Pembrolizumab (monoclonal antibody, anti‑PD‑1): checkpoint blockade to enhance T‑cell activity. Targets/pathways: EGFR on tumor cells, PD‑1/PD‑L1 immune checkpoint, host lymphocyte compartment for conditioning.