A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors
The patient or his/her guardian voluntarily signed the informed consent;
Age >18 years and ≤70 years, male or female;
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;
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).
Sequential
Metabolically Armed TIL cells
DrugEach subject receive metabolically armed TIL cells by intravenous infusion.
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.
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.
Overall survival(OS)
OS is measured from the date of the infusion of Meta10-TIL to the date of the subjects' death.
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.
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.
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Anhui Provincial Hospital
Lead sponsor
Leman Biotech Co., Ltd.
Collaborator
