Advanced Solid TumorsEarly Phase 1NCT07349160
Safety and Efficacy of Metabolically Armed Tumor-Infiltrating 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 Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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
- 10 Jan 2026to 20 Jan 2028
- 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:
- 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;
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- 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);
- 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
- 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]).
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- 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.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100000
Shuhang Wang, 8610-87788165
Ning Li
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.
- Main research objectives: To evaluate the safety of metabolically armed tumor-infiltrating lymphocytes (TILs) in patients with advanced solid tumors.
- 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- Metabolically Armed TIL cells.
- Keywords
- Meta10-TIL, Advanced solid tumors, IL-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolically Armed TIL cells.Drug
Also called Meta10-TIL
Each subject receive metabolically armed TIL cells by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metabolically Armed TIL cells. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Duration of Response (DOR)
To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessedby the investigator until disease progression or death due to any cause.
Measured: 1 year post Meta10-TIL infusion
Overall survival (OS)
OS is measured from the date of the infusion of Meta10-TIL to the date of the subjects' death.
Measured: 5 year post Meta10-TIL infusion
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.
- First posted16 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349160
- Sponsor's protocol ID
- LM-META10-TIL-12
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07349160
- Acronym / sponsor ID
- LM-META10-TIL-12
- Conditions
- Advanced Solid Tumors
- Keywords
- Meta10-TIL, Advanced solid tumors, IL-2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors
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.
- Main research objectives: To evaluate the safety of metabolically armed tumor-infiltrating lymphocytes (TILs) in patients with advanced solid tumors.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Metabolically Armed tumor-infiltrating lymphocytes (Meta10-TIL). | Experimental | Drug: Metabolically Armed TIL cells.Patients will receive a nonmyeloablative lymphodepletionl chemotherapy with cyclophosphamide and fludarabine before TIL cells infusion. Meta10-TIL cells will be infused on day 0. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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;
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolically Armed TIL cells.Also: Meta10-TILEach subject receive metabolically armed TIL cells by intravenous infusion. | Drug | Administration of Metabolically Armed tumor-infiltrating lymphocytes (Meta10-TIL). |
Primary outcome
Adverse Events (AEs)
Time frame: 1 year post Meta10-TIL infusion.
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.
4 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year post Meta10-TIL infusion
Duration of Response (DOR)
Time frame: 1 year post Meta10-TIL infusion
Overall survival (OS)
Time frame: 5 year post Meta10-TIL infusion
Progression-free survival (PFS)
Time frame: 1 year post Meta10-TIL infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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 Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 25 inclusion and 17 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 16 Jan 2026. 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 Shuhang Wang (8610-87788165, wangshuhang@cicams.ac.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?
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 16 Jan 2026.