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

Last updated: February 13, 2025
Sponsor: Grit Biotechnology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Head And Neck Cancer

Treatment

GT201 in combination with PD-1 inhibitors

Clinical Study ID

NCT06190275
GRIT-CD-CHN-201-003
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Voluntarily join the study, signed informed consent form,, willing and able tocomply with the study protocol;
  1. Age 18 to 70 years old;
  1. Diagnosis with recurrent or metastatic head and neck malignant tumors andreceived≤2 lines of systemic therapy;
  1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  1. Expected survival time of ≥ 12 weeks;
  1. Good function of vital organs;
  1. Subjects who enter this study due to poor treatment efficacy or intolerancemust have medical records describing their condition after previous treatmentor imaging records of lesion evaluation before tumor sampling;
  1. At least one measurable target lesion that meets the definition of RECIST v1.1after tumor sampling.

Exclusion

Exclusion Criteria:

  • 1.Patients with uncontrollable tumor-related pain as judged by the investigator;participants requiring analgesic medication must already have a stable analgesicregimen at the time of study entry; symptomatic lesions suitable for palliativeradiotherapy should be completed prior to study entry;

  • 2.Known mental illness, alcoholism, drug use or substance abuse;

  • 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planningto become pregnant within 1 year after cell infusion;

  • 4.Those who have received other clinical trial drug treatment within 4 weeks beforeNMA-LD chemotherapy or plan to participate in other clinical trial drug treatmentduring the study;

  • 5.The investigators determine that other conditions that make the patient notsuitable for enrollment.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: GT201 in combination with PD-1 inhibitors
Phase:
Study Start date:
May 12, 2024
Estimated Completion Date:
April 30, 2027

Study Description

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 tumors.

Secondary Objectives

  1. To assess the efficacy of GT201 in combination with PD-1 inhibitors in the treatment of advanced head and neck tumors according to RECIST v1.1.

  2. To monitor the pharmacokinetics of GT201 infusion in the treatment of advanced head and neck tumors: 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.

Connect with a study center

  • Shanghai Ninth People's Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

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