RecruitingNot ApplicableNCT06190275

Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors

A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Infusion (GT201) in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors


Sponsor

Grit Biotechnology

Enrollment

32 participants

Start Date

May 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 and neck tumor 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing GT201 — a personalized immune cell therapy made from your own tumor-fighting cells — combined with a checkpoint inhibitor (PD-1 inhibitor) for advanced or returning head and neck cancers. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with recurrent or metastatic head and neck cancer - You have received no more than 2 prior lines of cancer treatment - You have at least one tumor that can be safely sampled for cell preparation - Your general health and organ function meet study requirements **You may NOT be eligible if...** - You have had a severe autoimmune disease or require immune-suppressing medications - You have active, uncontrolled infections - Your heart, liver, kidney, or lung function is significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGT201 in combination with PD-1 inhibitors

GT201 in combination with a PD-1 inhibitor for advanced head and neck tumors


Locations(1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

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NCT06190275


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