Actively Recruiting
Safety and Efficacy of Metabolically Armed Tumor-lnfiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Led by Anhui Provincial Hospital · Updated on 2025-09-15
36
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
A
Anhui Provincial Hospital
Lead Sponsor
L
Leman Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors
CONDITIONS
Official Title
Safety and Efficacy of Metabolically Armed Tumor-lnfiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or guardian voluntarily signed informed consent
- Age greater than 18 years and less than or equal to 70 years, any gender
- Confirmed advanced solid tumors by histopathology or cytology with at least first-line treatment received
- Specific criteria for cervical cancer including prior failure of 1-3 systemic therapies or Stage III disease
- Confirmed locally advanced or metastatic liver cancers meeting defined staging and treatment failure criteria
- Advanced solid tumors progressed after standard therapy or intolerant to toxicity including TNBC, NSCLC, OC, HNC, CRC
- Residual lesions suitable for surgical resection or biopsy to generate TILs with specific size requirements
- Expected life expectancy of at least 3 months
- At least one measurable lesion after tumor resection/puncture for evaluation
- ECOG performance status of 0-1, stable brain metastases allowed with investigator assessment
- Adequate organ function including hematological, blood chemistry, pulmonary reserve, and heart function
- Recovery from prior anticancer therapy toxicities to Grade 1 or lower except certain stable conditions
- Asymptomatic for at least 6 months after immune checkpoint inhibitor-related diarrhea or colitis with normal colonoscopy
- Stable immune-related endocrinopathies controlled with hormone replacement (non-corticosteroid)
- Agreement to use effective contraception during study and for 1 year after infusion
You will not qualify if you...
- Presence of bone metastases only
- Active central nervous system metastases requiring medication or steroids within past 3 months
- Use of Chinese herbal medicine or botanical antitumor drugs within 1 week before preconditioning
- Systemic corticosteroids or immunosuppressive drugs within 2 weeks before preconditioning (except certain forms)
- Major surgery within 4 weeks before enrollment or planned major surgery during study (excluding TIL preparation)
- History of other malignancies within 3 years or concurrent malignancies except low-risk treated cancers
- Primary immunodeficiency disorders or history of organ transplantation
- Active hepatitis B or C infection
- Positive for HIV or syphilis antibodies
- Uncontrolled severe infections within 72 hours before infusion
- Live or attenuated vaccine within 4 weeks before preconditioning
- Unstable angina, recent myocardial infarction, thrombotic events, severe bleeding or DVT within specified timeframes
- History of neurological or psychiatric disorders including epilepsy or dementia
- Hypersensitivity to study drugs or components
- High bleeding risk based on tumor involvement or clinical history
- Receipt of investigational therapies within 30 days before consent
- Other conditions judged unsuitable by investigator including high-grade adverse events from prior immunotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
Research Team
F
Fanzheng Meng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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