eligibility_summary
Eligible: adults (>=18) with metastatic/recurrent HPV-16+ cancer, HLA-A02:01, measurable disease, ECOG 0-1, prior/declined standard therapy, <=3 treated, stable (>=1 mo) brain mets, HIV/HBV/HCV neg, adequate marrow/organ function, >4 wks since last systemic therapy, contraception, consent + companion protocols. Exclude: uncontrolled illness, severe allergy, cardiac disease/LVEF<=45% (some need stress test), O2<92%, HLA-A02:01 LOH/mutation, immunodeficiency/immunosuppression, severe autoimmune dz, live vaccine <30d, PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase II single-arm trial of E7 TCR-T cell therapy for metastatic HPV16-associated cancers. Interventions: (1) Cyclophosphamide (alkylator) + fludarabine (antimetabolite) lymphodepletion to reduce endogenous lymphocytes/Tregs and create a cytokine niche for engraftment. (2) E7 TCR-T cells: autologous gene-engineered T cells (TCR-T, not CAR-T) expressing an HLA-A02:01–restricted TCR that recognizes HPV16 E7 peptide, adoptive cellular gene therapy. (3) Aldesleukin (high-dose IL-2 cytokine therapy) to promote expansion/survival of transferred T cells. Targets/pathways: tumor cells expressing HPV16 E7 presented on MHC class I (HLA-A02:01), T-cell cytotoxic effector pathways, IL-2 signaling, and post-lymphodepletion homeostatic cytokines. Participants must be HPV16+ and HLA-A02:01.