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Advanced Solid TumorsEarly Phase 1NCT07106814

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

A Early Phase 1 study testing Metabolically Armed TIL cells in people with Advanced Solid Tumors, run by Anhui Provincial Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Metabolically Armed TIL cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
29 Aug 2025to 30 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.
  • Advanced solid tumors that have progressed after prior standard therapy or are intolerant to toxicity, for which no standard treatment options are currently available, or for other reasons cannot receive the current standard treatment, including but not limited to primary or metastatic triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) (excluding neuroendocrine tumors or mixed types with >10% neuroendocrine components), ovarian cancer (OC), head and neck cancer (HNC), and colorectal cancer (CRC).
  • 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 (no transfusions, platelet infusions, or growth factor support [except recombinant erythropoietin] within 7 days prior to enrollment):
  • Absolute neutrophil count (ANC)≥1x10^9/L;
  • Platelet count (PLT) ≥80 × 10^9/L;
  • Hemoglobin (Hb) ≥90.0 g/L;
  • Blood chemistry:
  • Estimated creatinine clearance ≥40 mL/min (calculated by Cockcroft-Gault formula);
  • Alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN);
  • Aspartate aminotransferase (AST) ≤3 × ULN;
  • Total bilirubin (TBIL) ≤2 mg/dL (subjects with Gilbert-Meulengracht syndrome ≤3 mg/dL);
  • Serum AST and ALT ≤5 × ULN (subjects with liver metastasis);
  • Adequate pulmonary reserve defined as ≤Grade 1 dyspnea and oxygen saturation >91% on room air;
  • Left ventricular ejection fraction (LVEF) ≥45% by echocardiography or multigated acquisition (MUGA) scan, with hemodynamic stability;
  • In the investigator's judgment, the subject must have recovered from prior anticancer therapy toxicities to Grade 1 or lower (except for specific Grade 2 or lower toxicities deemed irreversible in a short period of time as judged by the investigator, e.g., alopecia) and be eligible for preconditioning chemotherapy and TIL therapy;
  • Subjects with documented ≥Grade 2 diarrhea or colitis from prior immune checkpoint inhibitor therapy must be asymptomatic for ≥6 months before tumor resection, with normal colonoscopy (visual assessment) post-immunotherapy (excluding colorectal cancer patients);
  • Subjects with immune-related endocrinopathies (e.g., hypothyroidism) may enroll if stable for ≥6 weeks and controlled with hormone replacement therapy (non-corticosteroid);
  • Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception at the time of informed consent, and continue within 1 year after Meta10-TILs infusion.

Who cannot join

  • 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).
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  • 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]).
  • Patients who have received other investigational therapies within 30 days before signing informed consent.
  • Other conditions deemed ineligible for the study by the investigator (e.g., Grade ≥3 adverse events in previous immunotherapy).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fanzheng Meng, Ph.D contact

86+15244606128

mengfz@ustc.edu.cn

China1 site, 1 recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Fanzheng Meng, Ph.D, 86+15244606128, mengfz@ustc.edu.cn

    Lianxin Liu, Ph.D

    Recruiting

Other trials in China

About this study

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

Read the detailed description

This is an open-label study. This study is indicated for advanced solid tumors. The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.

  1. Main research objectives: To evaluate the safety of metabolically armed tumor-infiltrating lymphocytes (TILs) in patients with advanced solid tumors.
  2. Secondary research objectives: (1)To evaluate the objective response rate (ORR),duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR) of metabolically armed tumor-infiltrating lymphocytes (Meta10-TIL) with RECIST V1.1; (2) To evaluate the overall survival (OS); (3) Characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of Meta10-TILs.
Being tested
Metabolically Armed TIL cells
Keywords
Meta10-TIL, Advanced solid tumors, Liver cancer, Cervical cancer, IL-2
Medical subject headings
Liver Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metabolically Armed TIL cellsDrug

    Also called Meta10-TIL

    Each subject receive metabolically armed TIL cells by intravenous infusion.

Study groups in NCT07106814
Study groupRoleWhat they receive
Administration of Metabolically Armed tumor-infiltrating lymphocytes(Meta10-TIL)ExperimentalPatients will receive a nonmyeloablative lymphodepletion chemotherapy with cyclophosphamide and fludarabine before TIL cells infusion.Meta10-TIL cells will be infused on day 0.
Receives: Drug: Metabolically Armed TIL cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year post Meta10-TIL infusion

Secondary outcomes (4)

  1. Objective response rate(ORR)

    To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 as assessed by the investigator.

    Measured: 1 year post Meta10-TIL infusion

  2. Overall survival(OS)

    OS is measured from the date of the infusion of Meta10-TIL to the date of the subjects' death.

    Measured: 1year post Meta10-TIL infusion

  3. Duration of Response(DOR)

    To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to any cause.

    Measured: 1 year post Meta10-TIL infusion

  4. Progression-free survival(PFS)

    The time from the start of Meta10-TIL treatment for the subjects to the first disease progression or death for any reason.

    Measured: 1 year post Meta10-TIL infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start29 Aug 2025
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07106814
Sponsor's protocol ID
META10-TIL-09
Status last verified
Sep 2025
First submitted
30 Jul 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Metabolically Armed TIL cells in people with Advanced Solid Tumors, run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fanzheng Meng, Ph.D (86+15244606128, mengfz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events(AEs) (time frame: 1 year post Meta10-TIL infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07106814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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