Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours

NCT06397963 | Recruiting

• 1 other identifier: GRIT-CD-CHN-307-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (1)

• Objective response rate

  3 years

Study Arms (1)

GT307 injection treatment group

EXPERIMENTAL

Biological: GT307 injection

Interventions

GT307 injection BIOLOGICAL

GT307 injection to treat solid tumours

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.
• \. 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).
• \. Diagnosed as patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are unable to receive standard treatment.
• \. 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.
• \. 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).
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• \. Expected survival time of ≥12 weeks.
• \. 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;

You may not qualify if:

• 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.)
• \. 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.
• \. 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 \[≤60 days from signing the ICF\]).
• \. 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.
• \. A diagnosis of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory system diseases that severely impair pulmonary function.
• \. 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.
• \. 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.)
• \. A history of autoimmune diseases, or active autoimmune diseases requiring treatment with systemic corticosteroids or immunosuppressive agents (\>10 mg/day of prednisone or equivalent).
• \. Presence of refractory or intractable epilepsy, massive pleural effusion, ascites, pericardial effusion uncontrolled by medication, active gastrointestinal bleeding, or contraindications to IL-2 administration.

Sponsors & Collaborators

• Grit Biotechnology: lead
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Beijing GoBroad Hospital: collaborator
• Beijing Arion Cancer Center: collaborator

Study Sites (3)

Beijing Arion Cancer Center

Beijing, Beijing Municipality, China

RECRUITING

Beijing GoBroad hospital

Beijing, Beijing Municipality, China

RECRUITING

The Affiliated Hospital Of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Central Study Contacts

Zhengxiang Han, MD

CONTACT

+86 18052268612; cnhzxyq@163.com

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: April 30, 2024
• First Posted: May 3, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): April 18, 2027
• Study Completion (Estimated): April 18, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)