Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (gynecological Tumors)

Not Applicable

Recruiting

• Conditions: Gynecological Tumors; Solid Tumor
• Interventions: Biological: GT316

• Registration Number: NCT06145802
• Lead Sponsor: Grit Biotechnology

Brief Summary

This study is a single-arm, open clinical trial.This trial consists of two phases, dose-escalation and expansion, and the study process is divided into: a screening period, a sampling and production period, a NMA-LD chemotherapy period, a treatment and observation period, and a follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-09
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2026-03-09
• Study Completion: 2026-03-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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. Subjects with ≥3 untreated CNS metastases at screening (If the subject has ≤3 CNS metastases with a maximum diameter of <1cm, and there is no peritumor edema on brain imaging (MRI or CT).no evidence of progressive CNS disease on brain imaging at least 3 months after treatment, then subjects will be included.);
• 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 who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis,pericardial effusion, active gastrointestinal bleeding or IL-2 contraindications;
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GT316 treatment group	GT316	-

Primary Outcome Measures

Name	Time	Method
Incidience and severity of adverse events per CTCAE 5.0	3 years	To characterize the safety profile of autologous TIL injection (GT316) in patients with relapsed/metastatic advanced solid tumor as measured by incidience and severity of adverse events per CTCAE 5.0

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China