A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT307) in the Treatment of Metastatic and Recurrent Advanced Solid Tumors

A study testing GT307 injection in people with Advanced Solid Tumors, run by Grit Biotechnology at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This study adopts a single-center, single-arm, open-label design. It aims to evaluate the safety and tolerability of GT307 in patients with advanced solid tumors, as well as assess its pharmacokinetic profile and efficacy, and determine the optimal dosage regimen. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Advanced Solid Tumors
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: 0 participants
Where: 1 siteChina
Study dates: 30 Apr 2026to 31 May 2028
Phase: Interventional
Are there results?: None posted in the registry

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. Age between 18 and 70 years (cases over 70 years of age shall be jointly determined by the investigator and the sponsor's medical monitor).
3. Recurrent or metastatic solid tumors that have failed first-line systemic therapy, including but not limited to cervical cancer, malignant melanoma, non-small cell lung cancer, and head and neck cancer.
4. At least one lesion that has not received radiotherapy or other local therapies and from which tumor tissue can be obtained (as judged by the investigator), and the resected lesion can yield a tissue mass of ≥1.0 cm³ (from a single lesion or combined from multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes; minimally invasive procedures shall be used whenever possible.
5. After tumor sampling, at least one measurable lesion as defined by RECIST v1.1 is present, which has not received radiotherapy or other local therapies (unless such therapy was 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 ≥ 12 weeks.
8. Function of vital organs meets the following requirements:
Routine blood tests: reference ranges are provided below, and final judgment may be made by the investigator considering variations in normal reference ranges across central laboratories:
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 tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN. Criteria may be relaxed under the following conditions:
Confirmed liver metastasis: AST and/or ALT ≤ 5 × ULN;
Confirmed liver or bone metastasis: ALP ≤ 5 × ULN;
Confirmed Gilbert syndrome: total bilirubin (TBIL) ≤ 3.0 mg/dL.
Renal function tests: creatinine clearance (CrCL) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula), or serum creatinine (Cr) within normal range; and urine protein (Pro) < 2+.
Coagulation function tests: APTT ≤ 1.5 × ULN, and international normalized ratio (INR) or PT ≤ 1.5 × ULN.
Good cardiac function.
Good pulmonary function.
9. Women of childbearing potential who are not surgically sterilized must agree to use at least one medically accepted contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 1 year after the end of study treatment. Female participants of childbearing potential who are not surgically sterilized must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to cell infusion.
10. Adverse events resulting from prior therapy have resolved (CTCAE 5.0 ≤ Grade 1) before tumor sampling, or are judged by the investigator and the sponsor's physician to have no impact on this study.
11. Participants enrolled due to disease progression must have radiographic documentation of disease progression following the most recent prior therapy before tumor sampling.

Who cannot join

1. Patients with spinal cord compression that has not been relieved by surgery and/or radiotherapy shall not be enrolled (treated patients may be enrolled if clinical evidence shows symptom relief for ≥ 1 week prior to surgical sampling).
2. Patients with uncontrolled tumor-related pain as judged by the investigator. Participants requiring analgesic therapy must have 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 due to gastric fundal or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or patients assessed by the investigator to be at high risk of major bleeding, including but not limited to tumor encasement or invasion of major blood vessels (i.e., carotid artery, jugular vein, bronchial artery) and/or other high-risk features such as fistula, significant cavitary lesions, history of hemorrhage (≤ 60 days from signing ICF).
4. Active arterial/venous thrombotic events occurring within 3 months prior to screening, including but not limited to cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.
5. Presence of respiratory diseases severely affecting pulmonary function.
6. History of clinically significant cardiovascular diseases, including but not limited to:

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Congestive heart failure (New York Heart Association [NYHA] class > 2);
Unstable angina;
Myocardial infarction within the past 3 months;
Any supraventricular or ventricular arrhythmia requiring treatment or intervention.
7. Participants with ≥ 3 untreated central nervous system (CNS) metastases at screening (participants with ≤ 3 CNS metastases, maximum 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 may be enrolled).
8. History of autoimmune disease, or active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy (> 10 mg/day prednisone or equivalent).
9. Presence of refractory or intractable epilepsy, uncontrolled massive pleural effusion, ascites, pericardial effusion, etc., active gastrointestinal bleeding, or contraindications to IL 2 administration.
10. Malignancies other than the target indication diagnosed within 5 years prior to screening (excluding adequately treated basal cell or squamous cell skin cancer, radically resected ductal carcinoma in situ of the breast, etc.), unless the investigator determines that the benefits to the participant outweigh the risks.
11. Presence of infectious diseases at screening, such as HIV, syphilis, active hepatitis, active pulmonary tuberculosis, active EBV and/or CMV infection.
Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) may participate if HBV DNA is below the lower limit of normal (LLN) of the local laboratory.
Patients positive for anti-HCV antibody may participate if HCV RNA is below the LLN of the local laboratory.
Carriers shall receive antiviral therapy as appropriate and undergo regular quantitative nucleic acid testing during the study.
12. Patients with prior allogeneic bone marrow transplantation or solid organ transplantation.
13. Administration of anti-angiogenic agents such as VEGF/bevacizumab within 4 weeks prior to tumor sampling.
14. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, except for the following:
Bridging therapy;
For prior nitrosourea or mitomycin C chemotherapy, at least 6 weeks must elapse between the end of chemotherapy and the planned first study drug administration;
For prior small-molecule targeted therapy, at least 5 half-lives of the agent must elapse between the end of treatment and the planned first study drug administration.
15. Prior receipt of genetically modified or edited cell therapy products (excluding unmodified/unedited autologous immune cell therapy products administered more than 1 year before cell infusion).
16. History of hypersensitivity to any component of the study agents (including but not limited to autologous tumor-infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin 2, dimethyl sulfoxide [DMSO], human serum albumin [HSA], dextran 40, antibiotics [β lactams, gentamicin]).
17. Known psychiatric disorders, alcoholism, drug addiction or substance abuse.
18. Prior immune-related adverse events of Grade 3 or higher that did not resolve to CTCAE Grade 1 or lower within 28 days; any disease or condition (any other medical disorder, metabolic dysfunction, physical examination finding or laboratory abnormality) that would reasonably contraindicate the use of the investigational product, interfere with interpretation of study results, or place the participant at high risk of treatment 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 clinical trial drugs within 4 weeks prior to screening, or planning to participate in other investigational clinical trials during the study period.
21. Any other conditions deemed inappropriate for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Conditions: Advanced Solid Tumors
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 advanced solid tumors

Study groups in NCT07534813
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.

Evaluation of the safety of GT307 in the treatment of advanced solid tumors
Adverse events shall be reported and graded in accordance with CTCAE Version 5.0.
All adverse events (AEs) occurring from the signing of the informed consent form up to 24 weeks after GT307 infusion shall be collected.
Measured: 24 months
Evaluation of the tolerability of GT307 in the treatment of advanced solid tumors
Adverse events shall be reported and graded in accordance with CTCAE Version 5.0.
All adverse events (AEs) occurring from the signing of the informed consent form up to 24 weeks after GT307 infusion shall be collected.
All concomitant medications used from 28 days prior to signing the informed consent form up to 24 weeks after cell infusion shall be documented.
Measured: 24 months

Secondary outcomes (3)

overall response rate (ORR)
The proportion of patients whose tumor size reduces to the predefined criteria (complete response + partial response) and maintains for the specified duration, reflecting the short-term anti-tumor activity of a drug.
Measured: 24 months
Progression-Free Survival（PFS）
The time from randomization or initiation of treatment to the first documentation of disease progression or death from any cause.
Measured: 24 months
To monitor the pharmacokinetics of GT307 Injection in the treatment of advanced solid tumors.
PK blood samples will be collected from participants for pharmacokinetic monitoring of GT307 Injection via blood testing at the following time points: prior to the start of lymphodepletion conditioning therapy (on the day of initiation), prior to GT307 Injection infusion (Day -1), and on Days 3, 5, 7, 10, 14, 21 ± 3, 28 (Week 4) ± 3, 42 (Week 6) ± 3, 63 (Week 9) ± 7, 84 (Week 12) ± 7, 126 (Week 18) ± 7, 168 (Week 24) ± 7 post-infusion, as well as at follow-up visits every 3 months thereafter.
PK blood sampling may be discontinued if TIL are undetectable in peripheral blood on two consecutive occasions.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202631 May 2028

First posted16 Apr 2026
Study start30 Apr 2026 (estimated)
Primary completion31 May 2028 (estimated)
Study completion31 May 2028 (estimated)

Why it stopped: Due to procedural adjustments at the investigative site, domestic registration on the China health authority's platform must be finalized prior to re-submission on ClinicalTrials.gov. Therefore, we hereby withdraw the current submission.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorsStudies 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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07534813
Sponsor's protocol ID: GRIT-CD-CHN-307-024
Status last verified: Jun 2026
First submitted: 31 Mar 2026
Last updated: 9 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 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 Injection (GT307) in the Treatment of Metastatic and Recurrent Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07534813
Acronym / sponsor ID: GRIT-CD-CHN-307-024
Conditions: Advanced Solid Tumors
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Due to procedural adjustments at the investigative site, domestic registration on the China health authority's platform must be finalized prior to re-submission on ClinicalTrials.gov. Therefore, we hereby withdraw the current submission.
Enrolment: 0 participants (actual)
Lead sponsor: Grit BiotechnologyIndustry (pharma, biotech, devices)
Collaborators: Fudan University
Study start: 30 Apr 2026 (estimated)
Primary completion: 31 May 2028 (estimated)
Study completion: 31 May 2028 (estimated)
First posted: 16 Apr 2026 (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.

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. Age between 18 and 70 years (cases over 70 years of age shall be jointly determined by the investigator and the sponsor's medical monitor).
3. Recurrent or metastatic solid tumors that have failed first-line systemic therapy, including but not limited to cervical cancer, malignant melanoma, non-small cell lung cancer, and head and neck cancer.
4. At least one lesion that has not received radiotherapy or other local therapies and from which tumor tissue can be obtained (as judged by the investigator), and the resected lesion can yield a tissue mass of ≥1.0 cm³ (from a single lesion or combined from multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes; minimally invasive procedures shall be used whenever possible.
5. After tumor sampling, at least one measurable lesion as defined by RECIST v1.1 is present, which has not received radiotherapy or other local therapies (unless such therapy was administered more than 3 months prior and the lesion has demonstrated progression).

Key exclusion criteria (31 listed)

1. Patients with spinal cord compression that has not been relieved by surgery and/or radiotherapy shall not be enrolled (treated patients may be enrolled if clinical evidence shows symptom relief for ≥ 1 week prior to surgical sampling).
2. Patients with uncontrolled tumor-related pain as judged by the investigator. Participants requiring analgesic therapy must have 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 due to gastric fundal or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or patients assessed by the investigator to be at high risk of major bleeding, including but not limited to tumor encasement or invasion of major blood vessels (i.e., carotid artery, jugular vein, bronchial artery) and/or other high-risk features such as fistula, significant cavitary lesions, history of hemorrhage (≤ 60 days from signing ICF).
4. Active arterial/venous thrombotic events occurring within 3 months prior to screening, including but not limited to cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.
5. Presence of respiratory diseases severely affecting 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
GT307 injectionGT307 injection to treat advanced solid tumors	Biological	GT307 injection treatment group

Primary outcome

Evaluation of the safety of GT307 in the treatment of advanced solid tumors
Time frame: 24 months
Adverse events shall be reported and graded in accordance with CTCAE Version 5.0. All adverse events (AEs) occurring from the signing of the informed consent form up to 24 weeks after GT307 infusion shall be collected.
Evaluation of the tolerability of GT307 in the treatment of advanced solid tumors
Time frame: 24 months
Adverse events shall be reported and graded in accordance with CTCAE Version 5.0. All adverse events (AEs) occurring from the signing of the informed consent form up to 24 weeks after GT307 infusion shall be collected. All concomitant medications used from 28 days prior to signing the informed consent form up to 24 weeks after cell infusion shall be documented.

3 secondary outcomes

overall response rate (ORR)
Time frame: 24 months
Progression-Free Survival（PFS）
Time frame: 24 months
To monitor the pharmacokinetics of GT307 Injection in the treatment of advanced solid tumors.
Time frame: 24 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Individual participant dataSharing planned: No

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site 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 Advanced Solid Tumors, 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 24 inclusion and 31 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: withdrawn, as of the sponsor's last update on 9 Jun 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the safety of GT307 in the treatment of advanced solid tumors (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07534813.

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 9 Jun 2026.