Actively Recruiting
Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors
Led by Grit Biotechnology · Updated on 2026-04-24
32
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
G
Grit Biotechnology
Lead Sponsor
S
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to join the study and sign informed consent
- Age between 18 and 70 years old
- Diagnosed with recurrent or metastatic head and neck malignant tumors
- Have received two or fewer lines of systemic therapy
- Have at least one measurable lesion untreated by radiotherapy or local therapies and accessible for tumor tissue collection
- Able to provide a tissue block of at least 1.0 g for TIL preparation
- 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 at least 12 weeks
- Adequate function of major organs, meeting specific hematology, liver, renal, coagulation, cardiac, and pulmonary function requirements
- For women of childbearing potential, agree to use approved contraceptive methods during treatment and for 1 year after, and have a negative serum HCG test at screening
- Adverse reactions from prior therapies have resolved to grade 1 or lower per CTCAE v5.0 before tumor sampling
- Have medical or imaging records documenting disease status after prior therapy before tumor sampling
You will not qualify if you...
- Uncontrolled local or systemic infections in the oral cavity, head, or neck
- Active autoimmune disease or history requiring systemic corticosteroids or immunosuppressive drugs above specified doses
- Uncontrollable tumor-related pain or unstable analgesic treatment
- Bleeding events within 3 months prior to screening or high risk of major bleeding
- Arterial or venous thrombotic events within 6 months prior to screening
- History of interstitial pneumonia or active pneumonia impairing lung function
- Clinically significant cardiovascular disease as specified
- Having three or more untreated central nervous system metastases, except under specific stable conditions
- Unrelieved spinal cord compression
- History of other malignant tumors within 5 years, except certain treated skin or breast cancers
- Uncontrolled epilepsy, massive pleural effusion, ascites, pericardial effusion, or contraindications to interleukin-2 use
- Infectious diseases within 1 year prior to screening including HIV, syphilis, active hepatitis, active tuberculosis, or active EBV/CMV infection
- Use of anti-angiogenic agents within 4 weeks prior to tumor sampling
- Previous allogeneic bone marrow or solid organ transplantation
- Recent systemic anti-tumor therapy within 4 weeks before lymphodepletion conditioning, with some exceptions
- Previous genetically modified cell therapy within 1 year
- History of hypersensitivity to study drugs or components
- Known mental illness, alcoholism, drug addiction, or substance abuse
- Previous severe immunotherapy adverse reactions not resolved to grade 1 within 28 days
- Pregnant, lactating, or planning pregnancy within 1 year after cell infusion
- Use of other investigational products within 4 weeks prior to lymphodepletion or planned participation during study
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
Y
Yue He, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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