Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hangzhou Huasai Biomedicine Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age 18 to 75 years;
2. 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;
3. 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;
4. After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;
5. ECOG performance status ≤ 1;
6. Adequate organ and bone marrow function as assessed during the screening period;
7. Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography; no arrhythmia requiring treatment; Fridericia-corrected QT interval (QTcF) ≤ 470 ms; baseline oxygen saturation \> 91% on room air;
8. Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor sampling;
9. Agree to use effective non-pharmacological contraceptive measures from the time of signing informed consent until 1 year after TIL cell infusion;
10. Fully understand the trial and voluntarily sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol.
You may not be if
1. Patients with a history of severe hypersensitivity reactions to any drug used during the study;
2. Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;
3. 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;
4. Active autoimmune disease requiring systemic treatment during the study;
5. History of organ transplantation or hematopoietic stem cell transplantation;
6. Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease that, in the investigator's judgment, requires immunosuppressive medication during the study. However, physiological doses of glucocorticoids, intranasal or topical corticosteroids are allowed;
7. Received systemic anticancer therapy within 4 weeks prior to preconditioning, or plan to participate in another interventional clinical trial during the study;
8. Presence of acute or chronic infection, including: HIV positive, positive Treponema pallidum antibody, or clinically active hepatitis B or C; Active infection requiring systemic treatment or active tuberculosis infection;
9. Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study;
10. Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of lymphodepleting preconditioning, adoptive TIL therapy, and IL-2 adjuvant therapy;
11. Diagnosis of another primary malignancy within 5 years prior to screening, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ;
12. Severe respiratory disease;
13. Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation;
14. Known leptomeningeal metastasis; known other central nervous system metastases that are not effectively controlled after treatment or untreated;
15. Previous treatment with a similar cell therapy product;
16. Pregnant or breastfeeding women;
17. Known psychiatric disorders, alcoholism, drug abuse, or substance abuse, and any other condition that the investigator considers unsuitable for participation in this study.
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