HNSCCNCT06190275
Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors
A study testing GT201 in combination with PD-1 inhibitors in people with HNSCC, run by Grit Biotechnology at 1 site in China.
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 and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HNSCC
- What is being tested?
- GT201 in combination with PD-1 inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 malignant tumors and received≤2 lines of systemic therapy;
- 4. 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.
- 5. After tumor sampling, have at least one measurable lesion as defined by RECIST v1.1.
- 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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- 7. Expected survival time of ≥ 12 weeks;
- 8. 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);
- Total Bilirubin (TBIL) ≤ 1.5×ULN.
- The following exceptions apply:
- For confirmed liver metastases: AST and/or ALT ≤ 5×ULN;
- For confirmed liver or bone metastases: ALP ≤ 5×ULN;
- For confirmed Gilbert's syndrome: TBIL ≤ 3.0 mg/dL.
- Renal function:
- Creatinine Clearance (CrCL) ≥ 45 mL/min (calculated by the Cockcroft-Gault formula), or serum creatinine within the normal range.
- Coagulation function:
- Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5×ULN simultaneously.
- Adequate cardiac function.
- Adequate pulmonary function.
- 9. For women of childbearing potential who have not undergone surgical sterilization:
- Agree to use at least one medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 1 year after the end of study treatment;
- Serum human chorionic gonadotropin (HCG) test result must be negative at screening.
- 10. Adverse reactions caused by prior therapies have resolved to ≤ Grade 1 per CTCAE v5.0 before tumor sampling.
- 11. For subjects enrolled due to insufficient efficacy or intolerability of prior therapies, medical records documenting disease status after prior treatment or imaging records of lesion assessment must be available before tumor sampling.
Who cannot join
- 1. 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).
- 2. 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.
- 3. 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]).
- 4. Arterial/venous thrombotic events occurring within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism.
- 5. A history of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory diseases that severely impair pulmonary function.
- 6. 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.
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- 7. Subjects with ≥ 3 untreated central nervous system (CNS) metastases at screening. Exclusion exception: Subjects with ≤ 3 CNS metastases, with the largest lesion < 1 cm in diameter, no peritumoral edema on brain imaging (MRI or CT), and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment may be enrolled.
- 8. Ineligible for enrollment if spinal cord compression has not been relieved by surgery and/or radiotherapy. Exclusion exception: Subjects with active CNS metastases are excluded, except for those with stable brain metastases who have not required medical treatment for 3 months and are not dependent on corticosteroids.
- 9. 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.
- 10. 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.
- 11. 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.
- 12. Use of anti-angiogenic agents (e.g., bevacizumab, a VEGF inhibitor) within 4 weeks prior to surgical tumor sampling.
- 13. Previous allogeneic bone marrow transplantation or solid organ transplantation.
- 14. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, excluding the following situations:
- Bridging therapy;
- If prior treatment included nitrosourea or mitomycin chemotherapy, the interval between the end of chemotherapy and the expected start of lymphodepletion conditioning must be at least 6 weeks for enrollment;
- If prior treatment included small-molecule targeted therapy, the interval between the end of treatment and the expected start of lymphodepletion conditioning must be at least 5 half-lives of the drug for enrollment.
- 15. Previous receipt of genetically modified or edited cell therapy products (excluding autologous immune cell therapy products without genetic modification or editing if more than 1 year has passed since cell infusion).
- 16. A history of hypersensitivity reactions to any component of the drugs intended for use in the study, including but not limited to autologous tumor-infiltrating lymphocytes (TILs), cyclophosphamide, fludarabine, interleukin-2 (IL-2), dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, and antibiotics (β-lactam antibiotics, gentamicin).
- 17. Known history of mental illness, alcoholism, drug addiction, or substance abuse.
- 18. Previous grade 3 or higher adverse reactions to immunotherapy that failed to resolve to CTCAE grade 1 or below within 28 days; or any other disease or condition that could reasonably be suspected to contraindicate the use of investigational products, interfere with the interpretation of study results, or place the subject at high risk of treatment complications (including any other disease, metabolic disorder, abnormal physical examination finding, or abnormal laboratory test result).
- 19. Pregnant or lactating women; or women planning to become pregnant, lactate, or conceive within 1 year after cell infusion.
- 20. Receipt of other investigational products within 4 weeks prior to lymphodepletion conditioning, or planned participation in other investigational product studies during the study period.
- 21. Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200000
Yue He, PHD, +86-13501950200, william5218@126.com
Yue He, PHD
About this study
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 Tumors
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
- Being tested
- GT201 in combination with PD-1 inhibitors
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT201 in combination with PD-1 inhibitorsBiological
GT201 in combination with a PD-1 inhibitor for advanced head and neck tumors
| Study group | Role | What they receive |
|---|---|---|
| GT201 in combination with PD-1 inhibitors treatment group | Experimental | Not described Receives: Biological: GT201 in combination with PD-1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start12 May 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by Grit BiotechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190275
- Sponsor's protocol ID
- GRIT-CD-CHN-201-003
- Status last verified
- Apr 2026
- First submitted
- 19 Dec 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Tumors
- ClinicalTrials.gov ID
- NCT06190275
- Acronym / sponsor ID
- GRIT-CD-CHN-201-003
- Conditions
- HNSCC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 12 May 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT201 in combination with PD-1 inhibitors treatment group | Experimental | Biological: GT201 in combination with PD-1 inhibitors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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 malignant tumors and received≤2 lines of systemic therapy;
- 4. 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.
- 5. After tumor sampling, have at least one measurable lesion as defined by RECIST v1.1.
Key exclusion criteria (27 listed)
- 1. 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).
- 2. 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.
- 3. 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]).
- 4. Arterial/venous thrombotic events occurring within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism.
- 5. A history of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory diseases that severely impair pulmonary function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT201 in combination with PD-1 inhibitorsGT201 in combination with a PD-1 inhibitor for advanced head and neck tumors | Biological | GT201 in combination with PD-1 inhibitors treatment group |
Primary outcome
Incidience and severity of adverse events per CTCAE 5.0
Time frame: 3 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GT201 in combination with PD-1 inhibitors in people with HNSCC, run by Grit Biotechnology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue He, PHD (+86 13501950200, william5218@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidience and severity of adverse events per CTCAE 5.0 (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.