HNSCC Clinical Trial
Official title:
A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Infusion (GT201) in Combination With PD-1 Inhibitor for Advanced Head and Neck Squamous Cell Carcinomas (HNSCCs)
This study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head neck squamous carcinoma (HNSCC) subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases. The study consists of two phases, a dose-escalation phase and a dose-expansion phase.
Primary objectives a. To assess the safety and tolerability of GT201 in combination with PD-1 inhibitor in the treatment of advanced head and neck squamous carcinoma. Secondary Objectives 1. To assess the efficacy of GT201 in combination with PD-1 inhibitors in the treatment of advanced head and neck squamous carcinoma according to RECIST v1.1. 2. To monitor the pharmacokinetics of GT201 infusion in the treatment of advanced head and neck squamous carcinoma: duration of back infusion of GT201 in subjects, evaluate expansion status, and correlation with the effectiveness of GT201 infusion. To characterize serum levels of T cell related cytokines such as TNF-α, IFN-γ, IL-6. Purpose of exploratory study To analysis the changes of cell phenotypes and distribution of cell populations. To track the expansion of TIL clones by detecting T cell receptors (TCR)and other possible cytokines in peripheral blood. ;
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