A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.
Age 18 to 75 years;
Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer who have failed standard therapy or are intolerant to other standard therapies;
At least one tumor lesion that has not received radiotherapy or other local treatment within 28 days and can be surgically resected and/or biopsied for the preparation of autologous tumor-infiltrating lymphocytes;
After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;
Patients with a history of severe hypersensitivity reactions to any drug used during the study;
Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;
Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
Active autoimmune disease requiring systemic treatment during the study;
Single group
Cyclophosphamid
DrugCyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.
Fludarabine
DrugFludarabine is administered once daily via intravenous infusion for 3 consecutive days.
Interleukin 2 subcutaneous injection
DrugIL-2 is administered subcutaneously or intravenously once daily. The dose may be adjusted based on the subject's tolerance, including modifications to the dose, dosing frequency, or complete discontinuation of treatment, Up to three administrations.
Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
Evaluate the preliminary efficacy of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
Evaluate the pharmacokinetic (PK) characteristics of HS-IT101 injection.
Explore the pharmacodynamic (PD) characteristics of HS-IT101 injection.
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