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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HNSCC; Adults
• Intervention / Treatment: Biological: GT201 in combination with PD-1 inhibitors

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yue He, PHD; Phone Number: +86 13501950200; Email: william5218@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Ninth People's Hospital
      • Contact: Yue He, PHD; Phone Number: 13501950200; Email: william5218@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
• 2. Age 18 to 70 years old;
• 3. Diagnosis with recurrent or metastatic head and neck squamous cell carcinomas and received≤2 lines of systemic therapy;
• 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• 5. Expected survival time of ≥ 12 weeks;
• 6. Good function of vital organs;
• 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
• 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

• 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy 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 planning to become pregnant within 1 year after cell infusion;
• 4.Those who have received other clinical trial drug treatment within 4 weeks before tumor surgical sampling for TIL, bridging chemotherapy or NMA-LD chemotherapy or plan to participate in other clinical trial drug treatment during the study;
• 5.The investigators determine that other conditions that make the patient not suitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GT201 in combination with PD-1 inhibitors treatment group	Biological: GT201 in combination with PD-1 inhibitors; GT201 in combination with a PD-1 inhibitor for advanced (HNSCC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile Measured by Grade ≥3 TRAEs	Safety Profile Measured by Grade ≥3 TRAEs by CTCAE 5.0	3 years

Collaborators and Investigators

• Sponsor: Grit Biotechnology

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors
• Other Study ID Numbers: GRIT-CD-CHN-201-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No