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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adult, Solid Tumor, GT316

Intervention / Treatment
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* Biological: GT316


Participation Criteria
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Eligibility Criteria
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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.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever; 5.Patients with refractory or intractable epilepsy, drug-uncontrolled pleural effusion, abdominal effusion, pericardial effusion, active gastrointestinal bleeding or contraindications to IL-2; 6. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same； 7. Patients who have received allogeneic bone marrow transplantation or an organ allograft; 8.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);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GT316 treatment group<br> | Biological: GT316<br>* Autologous Tumor Infiltrating Lymphocyte Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile Measured By Grade ≥3 TRAEs | Safety Profile Measured By Grade ≥3 TRAEs of CTCAE 5.0 | 3 years |