RecruitingAdvanced Solid Tumors

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

Eligible age

19–70 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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

Sponsor: Anhui Provincial Hospital

✓ 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:
✓ 1. 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:
✓ 1. Recurrent/metastatic/persistent cervical cancer with prior failure (disease progression or intolerable toxicity) of at least 1 but no more than 3 systemic therapies;
✓ 2. Systemic therapy is defined as any chemotherapy or multi-drug combination chemotherapy regimen recommended by guidelines used for cervical cancer;
✓ 3. Chemotherapy or chemoradiotherapy administered as neoadjuvant or adjuvant therapy is not counted as a prior line of systemic therapy.
✓ 2. 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);

✕ 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.

Source: ClinicalTrials.gov · NCT07106814 · last updated 2025-09-15