clinical trial · NCT06236425
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC
H. Lee Moffitt Cancer Center and Research Institute·phase1·active not recruiting·n = 7
Squamous Cell Carcinoma of Head and NeckMetastatic Squamous Cell CarcinomaTBio-4101PembrolizumabPlatinum based chemotherapyCyclophosphamideFludarabineAldesleukin
brief summary
Phase 1b open-label study to evaluate the safety of selected TIL (TBio-4101) delivered after lymphodepleting chemotherapy and followed by intravenous (IV) bolus aldesleukin (IL-2) and pembrolizumab for patients with advanced HNSCC who have initially progressed on pembrolizumab or pembrolizumab/platinum chemotherapy.
started
Mar 14, 2024
primary completion
Apr 9, 2025
completion
Aug 1, 2026
last updated
Apr 1, 2026
official title
A Phase IB Clinical Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab With or Without Chemotherapy in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol