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

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06190275
• Other study ID #: GRIT-CD-CHN-201-003
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: Grit Biotechnology
• Contact: Yue He, PHD
• Phone: +86 13501950200
• Email: william5218[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adults
• Carcinoma, Squamous Cell
• HNSCC
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• GT201 in combination with PD-1 inhibitors
GT201 in combination with a PD-1 inhibitor for advanced (HNSCC)

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Profile Measured by Grade =3 TRAEs	Safety Profile Measured by Grade =3 TRAEs by CTCAE 5.0	3 years