eligibility_summary
Eligibility: adults 18–70 with advanced/metastatic/recurrent solid tumor that is HPV18+ and HLA‑DRB109:01, failed ≥1 prior line, ECOG 0–1, life ≥3 months, measurable disease, adequate organ function (blood counts, liver, kidney, LVEF ≥50%, SpO2 ≥92%), agree to contraception. Excludes transplant history, allergy to cyclophosphamide/fludarabine, recent major surgery/therapy/live vaccines/trials, uncontrolled heart/autoimmune disease, CNS mets, active infections (incl HIV, HBV/HCV, syphilis), planned immunosuppression, pregnancy/lactation, other malignancy, severe comorbidity/mental illness, prior gene therapy, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I, single-arm dose-escalation trial of HRYZ-T101, an autologous TCR-T cell therapy engineered to express a T-cell receptor that recognizes HPV18-derived peptide presented by HLA-DRB109:01 on tumor cells. Patients undergo leukapheresis, lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to enhance T-cell engraftment, then a single HRYZ-T101 infusion. Mechanism: engineered T cells bind HPV18 peptide–HLA complex, initiate TCR signaling, release cytotoxic molecules and cytokines, and kill tumor cells. Targets/pathways: HPV18-positive tumor cells in cervical, head & neck/oropharyngeal, anal, vulvar, vaginal, and penile cancers, antigen presentation via HLA-DRB109:01 (class II), T-cell effector pathways, lymphodepletion reduces immune sinks/Tregs.