Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors

NCT07349160 | Recruiting Early Phase 1

• 1 other identifier: LM-META10-TIL-12
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors

Conditions

Advanced Solid Tumors

Keywords

Meta10-TIL; Advanced solid tumors; IL-2

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  To characterize the safety profile of Meta10-TIL in patients with advanced solid tumor as assessed by incidence of adverse events. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

  1 year post Meta10-TIL infusion.

Secondary Outcomes (4)

• Objective response rate (ORR)

  1 year post Meta10-TIL infusion

• Duration of Response (DOR)

  1 year post Meta10-TIL infusion

• Overall survival (OS)

  5 year post Meta10-TIL infusion

• Progression-free survival (PFS)

  1 year post Meta10-TIL infusion

Study Arms (1)

Administration of Metabolically Armed tumor-infiltrating lymphocytes (Meta10-TIL).

EXPERIMENTAL

Patients will receive a nonmyeloablative lymphodepletionl chemotherapy with cyclophosphamide and fludarabine before TIL cells infusion. Meta10-TIL cells will be infused on day 0.

Drug: Metabolically Armed TIL cells.

Interventions

Metabolically Armed TIL cells. DRUG

Each subject receive metabolically armed TIL cells by intravenous infusion.

Also known as: Meta10-TIL

Administration of Metabolically Armed tumor-infiltrating lymphocytes (Meta10-TIL).

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient or his/her guardian voluntarily signed the informed consent；
• Age \>18 years and ≤70 years, male or female;
• Patients with advanced solid tumors who have been confirmed by histopathology or cytology:
• Patients with advanced solid tumors who have failed prior standard treatments (due to disease progression or intolerance to toxicity), currently have no standard treatment options, or are unable to tolerate the current standard treatment for other reasons;
• The subject has residual lesions suitable for surgical resection (≥1.5 cm) or biopsy (core needle biopsy specimens: ≥4 passes with 16G needle or ≥6 passes with 18G needle) to generate tumor-infiltrating lymphocytes (TILs). For cervical cancer subjects, tumor tissue meeting either ≥0.5 cm in diameter or ≥400 mm³ in volume is acceptable. Fresh tumor tissue for TIL production should preferably be obtained from proximal metastatic lymph nodes or the periphery of tumor lesions. The sampled lesion has not received local therapy (e.g., radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or such interventions have occurred ≥3 months prior and the lesion has progressed after local treatment;
• Expected life expectancy ≥3 months;
• After tumor resection/puncture, the subject must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for efficacy evaluation;
• Eastern Cooperative Oncology Group (ECOG) performance status was 0-1 (subjects with stable brain metastases require investigator assessment);
• Adequate organ function：
• Hematological (must meet the following criteria within 24 hours before apheresis/blood collection; no transfusions, platelet infusions, or growth factor support \[except recombinant erythropoietin\] within 7 days prior to enrollment):
• Absolute neutrophil count (ANC) ≥1 × 10⁹/L;
• Platelet count (PLT) ≥80 × 10⁹/L;
• Hemoglobin (Hb) ≥90.0 g/L;
• Blood chemistry:
• Estimated creatinine clearance ≥40 mL/min (calculated by Cockcroft-Gault formula);

You may not qualify if:

• Active central nervous system (CNS) metastases (except for stable brain metastases not requiring medication or steroid dependence for ≥3 months).
• Use of Chinese herbal medicine or botanical drugs with antitumor indications within 1 week before preconditioning.
• Systemic corticosteroid therapy (≥10 mg/day prednisone or equivalent) or other immunosuppressive drugs within 2 weeks before preconditioning (excluding inhaled, topical, or physiological replacement therapy).
• Subjects who have undergone major surgery within 4 weeks before enrollment (as assessed by the investigator) or planned major surgery during the study (excluding scheduled surgery for Meta10-TILs preparation)；Major surgery refers to Grade 3 \& 4 surgeries as defined by China's Administrative Measures for Clinical Application of Medical Technology (effective on May 1, 2009).
• History of other malignancies within 3 years before screening or concurrent malignancies (except for locally treated malignancies with no recurrence risk for ≥1 year, e.g., non-melanoma skin cancer, bladder cancer).
• Any form of primary immunodeficiency disorder (e.g., severe combined immunodeficiency \[SCID\] or acquired immunodeficiency syndrome \[AIDS\]).
• History of organ transplantation.
• Active hepatitis B (HBsAg positive or anti-HBc positive with HBV-DNA \>1000 copies/mL) or hepatitis C (HCV-RNA positive).
• Anti-HIV antibody positive or anti-syphilis antibody positive.
• Uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood culture ≤72 hours before Meta10-TILs infusion).
• Patients who have received a live or attenuated vaccination within 4 weeks before preconditioning.
• Unstable angina and/or myocardial infarction within 6 months before signing informed consent；Uncontrolled thrombotic events, severe bleeding, or deep vein thrombosis (DVT) within 12 months before signing informed consent.
• History of neurological or psychiatric disorders, including epilepsy or dementia.
• History of hypersensitivity to drugs (e.g., cyclophosphamide, fludarabine, IL-2, Meta10-TILs components, gentamicin, etc.).
• High bleeding risk per investigator assessment, including but not limited to: tumor encasement/infiltration of major blood vessels (e.g., carotid artery, jugular vein, bronchial artery)；other high-risk features (e.g., fistula, cavitary lesions, history of previous bleeding \[≤60 days\]).

Sponsors & Collaborators

• Leman Biotech Co., Ltd.: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100000, China

RECRUITING

Central Study Contacts

Shuhang Wang

CONTACT

8610-87788165; wangshuhang@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)