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Brief Title: TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC
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)
Study ID: NCT06236425
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Moffitt Cancer Center, Tampa, Florida, United States
Name: Kedar Kirtane, MD
Affiliation: Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR