Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors

A Single-arm Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injections for the Treatment of Advanced Solid Tumors

This trial is a multicenter, single-arm, open design designed to evaluate the safety and tolerability of Autologous Tumor Infiltrating Lymphocyte Injection in the treatment of patients with advanced solid tumors, as well as pharmacokinetic profiling and efficacy. The trial consists of two phases: dose-escalation and dose-expansion.

Study Overview

• Status: Terminated
• Conditions: Solid Tumor; Adult; GT316
• Intervention / Treatment: Biological: GT316

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • The first affiliated hospital of Zhengzhou university

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 1.The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
• 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
• 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

• 1.Patients with ≥3 untreated CNS metastases at the time of screening (patients were included if they had ≤3 CNS metastases with a maximum diameter of <1 cm and no peritumor edema on brain imaging (MRI or CT) and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment)
• 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone);
• 3. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• 4.Patients with refractory or intractable epilepsy, drug-uncontrolled pleural effusion, abdominal effusion, pericardial effusion, active gastrointestinal bleeding or contraindications to IL-2;
• 5. Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same；
• 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);

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: GT316 treatment group	Biological: GT316; Autologous Tumor Infiltrating Lymphocyte Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events per CTCAE 5.0	To characterize the safety profile of autologous TIL injection in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adverse events per CTCAE 5.0	3 years

Collaborators and Investigators

• Sponsor: Grit Biotechnology

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2023
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GRIT-CD-CHN-316-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No