Solid Tumor, AdultNCT06397963
Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours
A study testing GT307 injection in people with Solid Tumor, Adult, run by Grit Biotechnology at 3 sites in China.
Trial summary
This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- GT307 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesChina
- Study dates
- 18 Apr 2024to 18 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 participate in the study, sign the informed consent form, and be willing and able to comply with the study protocol.
- 2. Aged 18-70 years old (eligibility for subjects over 70 years old shall be jointly determined by the investigator and the medical monitor of the collaborating party).
- 3. Diagnosed as patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are unable to receive standard treatment.
- 4. Having at least one lesion that is untreated with radiotherapy or other local therapies, with accessible tumor tissue (assessed by the investigator), and from which a tissue block of ≥1.0 cm³ can be isolated after resection (either from a single lesion or a combination of multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes (TILs); minimally invasive procedures should be used whenever possible.
- 5. After tumor sampling, having at least one measurable lesion as defined by the RECIST v1.1 criteria, and the lesion must not have received radiotherapy or other local therapies (unless such therapies were administered more than 3 months prior and the lesion has demonstrated progression).
- 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 meeting the following requirements:
- Hematological parameters: Since the normal reference ranges may vary among different central laboratories, the final assessment shall be made by the investigator based on comprehensive judgment, with the following references:
- 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 parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) ≤2.5×Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤1.5×ULN. The criteria may be relaxed under the following circumstances:
- For subjects with confirmed liver metastases: AST and/or ALT ≤5×ULN;
- For subjects with confirmed liver or bone metastases: ALP ≤5×ULN;
- For subjects with confirmed Gilbert's syndrome: TBIL ≤3.0 mg/dL.
- Renal function parameters: Creatinine Clearance Rate (CrCL) ≥45 mL/min (calculated using the Cockcroft-Gault formula), or serum creatinine within the normal range; and urine protein <2+.
- Coagulation function parameters: Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN, and International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN simultaneously.
- Adequate cardiac function.
- Adequate pulmonary function.
- 9. Non-surgically sterilized women of childbearing potential must 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; the serum human chorionic gonadotropin (HCG) test result of such subjects must be negative within 7 days prior to cell infusion.
- 10. Adverse reactions caused by prior treatments must have resolved to CTCAE 5.0 Grade ≤1 before tumor sampling, or be judged by the investigator and the collaborating medical team as having no interference with the study.
- 11. For subjects enrolled in the study due to disease progression, imaging documentation confirming disease progression after the last prior treatment must be available before tumor sampling.
Who cannot join
- -1. Subjects with spinal cord compression that cannot be relieved by surgery and/or radiotherapy are not eligible for enrollment.
- (For treated subjects, enrollment is permitted if clinical evidence demonstrates that symptoms have been relieved for ≥1 week prior to surgical sampling.)
- 2. Subjects with uncontrolled tumor-related pain as assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at the time of study entry. Symptomatic lesions suitable for palliative radiotherapy must be treated before study entry.
- 3. A history of 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 (examples include but are 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 such as fistulas, significant cavitary lesions, a history of prior bleeding [≤60 days from signing the ICF]).
- 4. A history of arterial/venous thrombotic events occurring within 3 months prior to screening, including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, etc.
- 5. A diagnosis of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory system diseases that severely impair pulmonary function.
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- 6. A history of clinically significant cardiovascular diseases, including but not limited to:
- Congestive heart failure (NYHA classification > Class 2);
- Unstable angina pectoris;
- Myocardial infarction occurring within the past 3 months;
- Any supraventricular or ventricular arrhythmias requiring treatment or intervention.
- 7. Subjects with ≥3 untreated central nervous system (CNS) metastases at screening.
- (Enrollment is permitted if subjects have ≤3 CNS metastases, with the largest diameter <1 cm, 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.)
- 8. A history of autoimmune diseases, or active autoimmune diseases requiring treatment with systemic corticosteroids or immunosuppressive agents (>10 mg/day of prednisone or equivalent).
- 9. Presence of refractory or intractable epilepsy, massive pleural effusion, ascites, pericardial effusion uncontrolled by medication, active gastrointestinal bleeding, or contraindications to IL-2 administration.
- 10. A history of malignant tumors other than the target indication within 5 years prior to screening (excluding adequately treated basal cell or squamous cell skin cancer, surgically resected ductal carcinoma in situ of the breast, etc.), unless the investigator determines that the potential benefits to the subject outweigh the risks.
- 11. A history of infectious diseases within 1 year prior to screening, such as HIV, syphilis, active viral hepatitis, active tuberculosis, active EBV and/or CMV infection; or a history of active tuberculosis infection for more than 1 year without standard treatment. Subjects with active hepatitis B or C are excluded.
- HBsAg- or HBcAb-positive subjects may participate in the study if their HBV DNA test result is below the lower limit of normal (LLN) of the testing laboratory at the study site.
- HCV antibody-positive subjects may participate if their HCV RNA test result is below the LLN of the testing laboratory at the study site.
- For carriers enrolled in the study, antiviral treatment should be arranged as appropriate, and regular nucleic acid copy number quantitative testing should be performed during the study period.
- 12. Subjects with a history of prior allogeneic bone marrow transplantation or solid organ transplantation.
- 13. Use of anti-angiogenic agents (e.g., bevacizumab, a VEGF inhibitor) within 4 weeks prior to sampling.
- 14. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, except for the following circumstances:
- Bridge therapy;
- If prior treatment included nitrosourea or mitomycin chemotherapy, the interval between the end of chemotherapy and the expected first study treatment administration 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 first study treatment administration must be at least 5 half-lives of the drug for enrollment.
- 15. Prior receipt of genetically modified or edited cell therapy products (excluding autologous immune cell therapy products without genetic modification or editing that were administered more than 1 year before the date of 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. A known history of mental illness, alcoholism, drug addiction, or substance abuse, etc.
- 18. A history of grade 3 or higher adverse reactions from prior immunotherapy that failed to resolve to CTCAE Grade 1 or lower within 28 days; any disease or condition (including other illnesses, metabolic disorders, physical examination findings, or abnormal laboratory test results) that would reasonably raise suspicion of contraindicating the use of study drugs, interfere with the interpretation of study results, or place the subject at high risk of treatment-related complications.
- 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 drugs/study treatments within 4 weeks prior to screening, or plans to participate in other investigational drugs/study treatments during the study period.
- 21. Other circumstances deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Arion Cancer Center
Beijing, Beijing Municipality
Zhiqiang Ma, +86 13910724116, mzq6211@163.com
Zhiqiang Ma
- Recruiting
Beijing GoBroad hospital
Beijing, Beijing Municipality
Shasha Wang, +86 13641268212, 390150823@qq.com
Shasha Wang
- Recruiting
The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Zhengxiang Han, MD, +86 18052268612, cnhzxyq@163.com
Zhengxiang Han
About this study
Official title: A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours
This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
- Conditions
- Solid Tumor, Adult
- Being tested
- GT307 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT307 injectionBiological
GT307 injection to treat solid tumours
| Study group | Role | What they receive |
|---|---|---|
| GT307 injection treatment group | Experimental | Not described Receives: Biological: GT307 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adcersed events per CTCAE 5.0
To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Measured: 3 years
Secondary outcomes (1)
Objective response rate
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
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 posted3 May 2024
- Study start18 Apr 2024
- Primary completion18 Apr 2027 (estimated)
- Study completion18 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, Beijing GoBroad Hospital, Beijing Arion Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397963
- Sponsor's protocol ID
- GRIT-CD-CHN-307-002
- Status last verified
- Jan 2026
- First submitted
- 30 Apr 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 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 (GT307 Injection ) for Treatment of Patients With Solid Tumours
- ClinicalTrials.gov ID
- NCT06397963
- Acronym / sponsor ID
- GRIT-CD-CHN-307-002
- Conditions
- Solid Tumor, Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, Beijing GoBroad Hospital, Beijing Arion Cancer Center
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 18 Apr 2027 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 3 May 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, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT307 injection treatment group | Experimental | Biological: GT307 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 1. Voluntarily participate in the study, sign the informed consent form, and be willing and able to comply with the study protocol.
- 2. Aged 18-70 years old (eligibility for subjects over 70 years old shall be jointly determined by the investigator and the medical monitor of the collaborating party).
- 3. Diagnosed as patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are unable to receive standard treatment.
- 4. Having at least one lesion that is untreated with radiotherapy or other local therapies, with accessible tumor tissue (assessed by the investigator), and from which a tissue block of ≥1.0 cm³ can be isolated after resection (either from a single lesion or a combination of multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes (TILs); minimally invasive procedures should be used whenever possible.
- 5. After tumor sampling, having at least one measurable lesion as defined by the RECIST v1.1 criteria, and the lesion must not have received radiotherapy or other local therapies (unless such therapies were administered more than 3 months prior and the lesion has demonstrated progression).
Key exclusion criteria (33 listed)
- -1. Subjects with spinal cord compression that cannot be relieved by surgery and/or radiotherapy are not eligible for enrollment.
- (For treated subjects, enrollment is permitted if clinical evidence demonstrates that symptoms have been relieved for ≥1 week prior to surgical sampling.)
- 2. Subjects with uncontrolled tumor-related pain as assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at the time of study entry. Symptomatic lesions suitable for palliative radiotherapy must be treated before study entry.
- 3. A history of 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 (examples include but are 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 such as fistulas, significant cavitary lesions, a history of prior bleeding [≤60 days from signing the ICF]).
- 4. A history of arterial/venous thrombotic events occurring within 3 months prior to screening, including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, etc.
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 |
|---|---|---|
| GT307 injectionGT307 injection to treat solid tumours | Biological | GT307 injection treatment group |
Primary outcome
Incidence and severity of adcersed events per CTCAE 5.0
Time frame: 3 years
To characterize the safety profile of autologous TIL injection（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
1 secondary outcome
Objective response rate
Time frame: 3 years
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 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GT307 injection in people with Solid Tumor, Adult, run by Grit Biotechnology at 3 sites 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 24 inclusion and 33 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Zhengxiang Han, MD (+86 18052268612, cnhzxyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adcersed 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 26 Jan 2026.