Actively Recruiting
Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-16
36
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient or guardian has voluntarily signed informed consent
- Age greater than 18 years and less than or equal to 70 years, male or female
- Advanced solid tumor confirmed by histopathology or cytology
- Failed prior standard treatments or have no standard treatment options or cannot tolerate current standard treatment
- Residual lesions suitable for surgical resection (≥1.5 cm) or biopsy (≥4 passes with 16G needle or ≥6 passes with 18G needle) for TIL generation
- For cervical cancer, tumor tissue ≥0.5 cm diameter or ≥400 mm³ volume is acceptable
- Fresh tumor tissue preferably from proximal metastatic lymph nodes or tumor lesion periphery
- Sampled lesion not treated locally within 3 months or has progressed after local treatment
- Expected life expectancy of at least 3 months
- At least one measurable lesion after tumor resection/biopsy according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function including hematological, blood chemistry, pulmonary reserve, and heart function as specified
- Recovery from prior anticancer therapy toxicities to Grade 1 or lower (with some exceptions)
- For prior immune checkpoint inhibitor therapy, asymptomatic with normal colonoscopy after ≥6 months if had ≥Grade 2 diarrhea or colitis (except colorectal cancer patients)
- Stable immune-related endocrinopathies controlled with hormone replacement for ≥6 weeks
- Agreement to use highly effective contraception during consent and for 1 year after Meta10-TIL infusion
You will not qualify if you...
- Active central nervous system metastases except stable brain metastases without medication or steroid dependence for ≥3 months
- Use of Chinese herbal medicine or botanical drugs with antitumor effects within 1 week before preconditioning
- Use of systemic corticosteroids (≥10 mg prednisone or equivalent) or other immunosuppressants within 2 weeks before preconditioning (excluding inhaled, topical, or replacement therapy)
- Major surgery within 4 weeks before enrollment or planned major surgery during the study (excluding scheduled surgery for Meta10-TIL preparation)
- History of other malignancies within 3 years or concurrent malignancies except certain treated non-recurrent cancers
- Primary immunodeficiency disorders or history of organ transplantation
- Active hepatitis B or C infections
- Positive for HIV or syphilis antibodies
- Uncontrolled acute life-threatening infections
- Live or attenuated vaccine within 4 weeks before preconditioning
- Unstable angina, recent myocardial infarction, uncontrolled thrombotic events, severe bleeding, or deep vein thrombosis within specified periods
- History of neurological or psychiatric disorders including epilepsy or dementia
- Hypersensitivity to drugs used in the study
- High bleeding risk including tumor involvement of major blood vessels or other high-risk features
- Receipt of other investigational therapies within 30 days before consent
- Other conditions judged ineligible by the investigator such as severe adverse events in prior immunotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100000
Actively Recruiting
Research Team
S
Shuhang Wang
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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