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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: GT307 injection

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhou; Phone Number: +86-21- 64041990; Email: zhou.jian@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • ZhongShan Hospital FuDan University
      • Principal Investigator: Jian Zhou
      • Contact: Jian Zhou; Phone Number: +86-21- 64041990; Email: zhou.jian@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 7. Expected survival time ≥ 12 weeks.

• 8. Function of vital organs meets the following requirements:

  1. 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.

  2. 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.
  3. 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+.
  4. Coagulation function tests: APTT ≤ 1.5 × ULN, and international normalized ratio (INR) or PT ≤ 1.5 × ULN.
  5. Good cardiac function.
  6. 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.

Exclusion Criteria:

• 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:

  1. Congestive heart failure (New York Heart Association [NYHA] class > 2);
  2. Unstable angina;
  3. Myocardial infarction within the past 3 months;
  4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GT307 injection treatment group	Biological: GT307 injection; GT307 injection to treat advanced solid tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	24 months

Collaborators and Investigators

• Sponsor: Grit Biotechnology
• Collaborators: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GRIT-CD-CHN-307-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No