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

NCT07106814 | Recruiting Early Phase 1

• 1 other identifier: META10-TIL-09
• 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; Liver cancer; Cervical cancer; 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

• Overall survival(OS)

  1year post Meta10-TIL infusion

• Duration of Response(DOR)

  1 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 lymphodepletion 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 and have received at least first-line of treatment:
• Recurrent/metastatic/persistent (persistent defined as disease progression after initial treatment) cervical cancer, including squamous cell carcinoma (SCC), adenosquamous carcinoma (ASC), and adenocarcinoma (AC), and not eligible for curative surgery and/or radiotherapy:
• Recurrent/metastatic/persistent cervical cancer with prior failure (disease progression or intolerable toxicity) of at least 1 but no more than 3 systemic therapies;
• Systemic therapy is defined as any chemotherapy or multi-drug combination chemotherapy regimen recommended by guidelines used for cervical cancer;
• Chemotherapy or chemoradiotherapy administered as neoadjuvant or adjuvant therapy is not counted as a prior line of systemic therapy.
• Or, classified as Stage Ⅳ cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO 2018) staging criteria (studies have shown that patients with early-stage cancer may have better outcomes after TIL therapy. After confirming significantly superior efficacy compared to marketed TIL products, researchers can relax staging criteria according to their judgment);
• Histologically or cytologically confirmed locally advanced/metastatic liver malignancies (including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and metastatic liver cancer):
• For hepatocellular carcinoma (HCC), classified as Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B unsuitable for local therapy or progressed after local therapy;
• For locally advanced liver cancer, patients must have failed at least first-line systemic therapies recommended by guidelines (disease progression or intolerable toxicity);
• Unresectable intrahepatic cholangiocarcinoma patients must have failed at least 1 but no more than 3 prior systemic therapies recommended by guidelines(disease progression or intolerable toxicity);
• Metastatic liver cancer ineligible for curative surgery based on primary tumor TNM (Tumor Node Metastasis) staging; for metastatic liver cancer, patients must have failed at least 2 but no more than 3 guideline-recommended systemic therapies (disease progression or intolerable toxicity);
• Liver function Child-Pugh score ≤7;
• Or patients deemed by the investigator to be unsuitable for existing standard treatments, or who refuse standard therapy.

You may not qualify if:

• Presence of bone metastases only.
• 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.).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Leman Biotech Co., Ltd.: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Fanzheng Meng, Ph.D

CONTACT

86+15244606128; mengfz@ustc.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 29, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)