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

NCT06190275 | Recruiting

• 1 other identifier: GRIT-CD-CHN-201-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HNSCC

Outcome Measures

Primary Outcomes (1)

• Incidience and severity of adverse events per CTCAE 5.0

  To characterize the safety profile of autologous TIL injection (GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidience and severity of adverse events per CTCAE 5.0

  3 years

Study Arms (1)

GT201 in combination with PD-1 inhibitors treatment group

EXPERIMENTAL

Biological: GT201 in combination with PD-1 inhibitors

Interventions

GT201 in combination with PD-1 inhibitors BIOLOGICAL

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

GT201 in combination with PD-1 inhibitors treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;
• \. Age 18 to 70 years old;
• \. Diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy;
• \. Have at least one measurable lesion that is untreated with radiotherapy or other local therapies, is accessible for tumor tissue collection (assessed by the investigator), and can provide a tissue block with a mass ≥1.0 g (approximately 1.5 cm in diameter) for autologous tumor-infiltrating lymphocyte (TIL) preparation. The tissue collection procedure should be minimally invasive whenever possible.
• \. After tumor sampling, have at least one measurable lesion as defined by RECIST v1.1.
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• \. Expected survival time of ≥ 12 weeks;
• \. Adequate function of major organs, with the following requirements (administration of any blood components or cell growth factors is not allowed within 14 days prior to surgery):
• Hematology:
• Absolute Neutrophil Count (ANC) ≥ 1.0×10⁹/L;
• Lymphocyte Count (LC) ≥ 0.5×10⁹/L;
• Platelet Count (PLT) ≥ 80×10⁹/L;
• Hemoglobin (Hb) ≥ 90 g/L.
• Liver function:
• Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5×Upper Limit of Normal (ULN);

You may not qualify if:

• \. Uncontrolled local or systemic infections of the oral cavity, head, or neck; any active autoimmune disease, history of autoimmune disease, or disease requiring systemic corticosteroid therapy or immunosuppressive drugs (prednisone equivalent dose \> 10 mg/day).
• \. Subjects with uncontrollable tumor-related pain assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at study entry; symptomatic lesions eligible for palliative radiotherapy should have completed treatment prior to study entry.
• \. Bleeding events occurring within 3 months prior to screening, including but not limited to gastrointestinal bleeding caused by fundic or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or subjects assessed by the investigator as having a high risk of major bleeding, including but not limited to tumors encasing or invading major blood vessels \[i.e., carotid artery, jugular vein, bronchial artery\] and/or exhibiting other high-risk features (e.g., fistula, significant cavitary lesions, history of bleeding \[≤ 60 days from signing the ICF\]).
• \. Arterial/venous thrombotic events occurring within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism.
• \. A history of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory diseases that severely impair pulmonary function.
• \. A history of clinically significant cardiovascular disease, including but not limited to: (1) congestive heart failure (NYHA class \> 2); (2) unstable angina pectoris; (3) myocardial infarction within the past 3 months; (4) any supraventricular or ventricular arrhythmia requiring treatment or intervention.
• \. A history of malignant tumors other than the target indication within 5 years prior to screening (excluding adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, and breast ductal carcinoma in situ after radical resection), unless the investigator determines that the benefits to the subject outweigh the risks.
• \. Presence of refractory or intractable epilepsy, massive pleural effusion, ascites, pericardial effusion, etc., that cannot be controlled by medication, or contraindications to interleukin-2 (IL-2) use.
• \. A history of infectious diseases within 1 year prior to screening, such as HIV, syphilis, active viral hepatitis, active pulmonary tuberculosis, active EBV and/or CMV infection; or a history of active pulmonary tuberculosis infection for more than 1 year without standard treatment. Active hepatitis B or hepatitis C is excluded. Enrollment exceptions:
• Subjects positive for HBsAg or HBcAb may participate if HBV DNA test results are below the lower limit of normal (LLN) at the testing site;
• Subjects positive for HCV antibody may participate if HCV RNA test results are below the LLN at the testing site.
• Carriers enrolled in the study should receive antiviral therapy as appropriate and undergo regular nucleic acid copy number quantitative testing during the study period.
• \. Use of anti-angiogenic agents (e.g., bevacizumab, a VEGF inhibitor) within 4 weeks prior to surgical tumor sampling.
• \. Previous allogeneic bone marrow transplantation or solid organ transplantation.
• \. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, excluding the following situations:

Sponsors & Collaborators

• Grit Biotechnology: lead
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Yue He, PHD

CONTACT

+86 13501950200; william5218@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: May 12, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)