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

NCT07534813 | Not Yet Recruiting

• 1 other identifier: GRIT-CD-CHN-307-024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• overall response rate (ORR)

  24 months

• Progression-Free Survival（PFS）

  24 months

• To monitor the pharmacokinetics of GT307 Injection in the treatment of advanced solid tumors.

  24 months

Study Arms (1)

GT307 injection treatment group

EXPERIMENTAL

Biological: GT307 injection

Interventions

GT307 injection BIOLOGICAL

GT307 injection to treat advanced solid tumors

GT307 injection treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate in the study, sign the informed consent form, and be willing and able to comply with the study protocol.
• \. 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).
• \. 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.
• \. 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.
• \. 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).
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• \. Expected survival time ≥ 12 weeks.
• \. 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;

You may not qualify if:

• \. 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).
• \. 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.
• \. 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).
• \. 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.
• \. Presence of respiratory diseases severely affecting pulmonary function.
• \. History of clinically significant cardiovascular diseases, including but not limited to:
• 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.
• \. 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).
• \. History of autoimmune disease, or active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy (\> 10 mg/day prednisone or equivalent).
• \. Presence of refractory or intractable epilepsy, uncontrolled massive pleural effusion, ascites, pericardial effusion, etc., active gastrointestinal bleeding, or contraindications to IL 2 administration.
• \. 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.
• \. Presence of infectious diseases at screening, such as HIV, syphilis, active hepatitis, active pulmonary tuberculosis, active EBV and/or CMV infection.

Sponsors & Collaborators

• Grit Biotechnology: lead
• Fudan University: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Central Study Contacts

Jian Zhou

CONTACT

+86-21- 64041990; zhou.jian@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)