Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies

Exclusion Criteria

• •1. Central nervous system metastasis or meningeal metastasis with clinical symptoms, or there is other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for inclusion according to the judgment of the researcher;
• •2. Subjects with a history of second malignancy within 5 years before signing the informed consent;
• •3. Patients who had previously received PD-L1 mAb;
• •4. Those who have active infection within 1 week before apheresis and currently need systematic anti infection treatment;
• •5. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments within 2 weeks before apheresis, Except for the following:
• •1. Nitrosourea or mitomycin C were within 6 weeks before single harvest;
• •2. Oral fluorouracils and small molecule targeted drugs were taken 1 week before apheresis.
• •6. Within 2 weeks before apheresis:
• •1. Have received systemic glucocorticoid (prednisone \> 10mg/day or equivalent dose of similar drugs) or other immunosuppressant treatment; Except for the following cases: local, eye, intra-articular, intranasal and inhaled glucocorticoids; Short term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);
• •2. Used immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc;
• •7. Within 4 weeks before apheresis:
• •1. Have received other unlisted clinical research drugs or treatments;
• •2. Have undergone major organ surgery (excluding puncture biopsy) or significant trauma, or need to undergo elective surgery during the trial;
• •3. Used live attenuated vaccine;
• •8. Currently suffering from interstitial lung disease;
• •9. Had received PD-1 monoclonal antibody treatment and had ≥ grade 2 Irae; Or other immunotherapy with ≥ grade 3 Irae;
• •10. Patients with active, or had, and relapsed autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., except for clinically stable autoimmune thyroid disease and well controlled type I diabetes.
• •11. The adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 and the evaluation is ≤ 1 (except for the toxicity without safety risk judged by the researchers such as hair loss).
• •12. Have a history of immune deficiency, including HIV antibody test positive;
• •13. Hepatitis B: the titer of HBsAg (+) and/or hepatitis B DNA is higher than that of the research center. And/or hepatitis C: anti HCV positive; And/or Treponema pallidum antibody positive;
• •14. Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
• •1. There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, ⅱ-ⅲ degree atrioventricular block, etc.
• •2. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular events occurred within 6 months before the first administration.
• •3. New York Heart Association (NYHA) cardiac function grade ≥ grade II or left ventricular ejection fraction (LVEF) \< 50%, or structural heart disease with high risk judged by other researchers;
• •4. Clinically uncontrollable hypertension.
• •15. Serous effusion beyond clinical control is not suitable to be included in the group according to the judgment of the researcher;
• •16. Known alcohol or drug dependence;
• •17. Mental disorder or poor compliance;
• •18. Women with reproductive needs and pregnant or lactating women;
• •19. There are other serious or uncontrolled systemic diseases, or other reasons that are not suitable to participate in this clinical study.