Advanced Solid Tumor
Conditions
Interventions
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 75 years old (including threshold); 2. Patients with advanced solid tumors confirmed by histology or cytology: a. Patients with advanced non-small cell lung cancer (both male and female); Excluding neuroendocrine tumors or mixed neuroendocrine tumors with>10% tumor cells; b. Patients with advanced cervical cancer; c. Patients with advanced breast cancer (female); 3. Failure after at least one systemic treatment (disease progression or inability to tolerate), and evaluation by the researcher that there is no acceptable effective treatment or refusal to further accept other treatment methods; 4. There is at least one tumor lesion that has not received radiation therapy or other local treatment within 28 days, and at least a tissue block with a volume of approximately 1 cm ^ 3 can be obtained, or sufficient tissue can be prepared for TIL (single lesion source or multiple lesions combined, minimally invasive treatment as much as possible); 5. At least one measurable lesion that meets the definition of RECIST 1.1 standard and has not received radiotherapy or other local treatment (unless these treatments occur earlier than 28 days and the lesion shows significant progression); 6. ECOG score=3 months; 8. During the evaluation conducted within 10 days of the screening period, sufficient organ and bone marrow function was defined as follows: Blood routine: Neutrophil count>=1.5 × 10 ^ 9/L, platelet count>=90 × 10 ^ 9/L, hemoglobin>=90g/L (no blood transfusion or erythropoietin treatment within 14 days); Liver function: ALT and AST levels=45 mL/min (Cockcroft Fault formula); Coagulation function: activated partial thromboplastin time (APTT)=50%; Asymptomatic or poorly controlled arrhythmia: no prolongation of QT interval, QTc60% or FEV1/FVC>0.7; 9. Before tumor sampling, the adverse reactions caused by previous treatment have returned to CTCAE 5.0<=1 level (excluding toxicity that researchers have determined to have no safety risk such as hair loss); 10. Subjects who agree to take effective non pharmacological contraceptive measures within 180 days from the signing of the informed consent form to the end of the trial; 11. Those who fully understand this experiment and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. It is known that there has been a severe allergic reaction (>=level 3) to the relevant drugs used in the experiment (cyclophosphamide, fludarabine, interleukin-2), their active ingredients, and/or any excipients; 2. Any uncontrollable clinical issues, including but not limited to: Hypertension with poor drug control (blood pressure>=150/90mmHg at rest after medication); Poorly controlled diabetes; Heart disease (defined by the New York Heart Association as Class III/IV congestive heart failure or heart block); 3. The following conditions occurred within 6 months before screening: deep vein thrombosis or pulmonary embolism; miocardial infarction; Severe or unstable arrhythmia or angina pectoris; Percutaneous coronary intervention therapy, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accidents, transient ischemic attacks, cerebral embolism; 4. Active autoimmune diseases or organ transplant recipients who require systemic treatment during the study period, or a history of such diseases within the past 2 years; 5. Have used any immunosuppressive drugs, such as corticosteroids, within 14 days prior to enrollment. However, it is allowed to use physiological doses of glucocorticoids (i.e. hydrocortisone or other equivalent drugs with a concentration of<=12mg/m2/day), and inhaled, nasal or local corticosteroids are allowed; 6. Symptomatic brain metastasis. For patients with asymptomatic brain metastasis or stable symptoms after treatment with brain metastasis lesions, they can participate in this study if they meet all the following criteria: a. If there are measurable lesions outside the central nervous system, radiation or surgical treatment of brain metastasis tumors is allowed; b. The maximum diameter of the lesion<=1cm and the number of lesions<=3 cases; c. No metastasis to the meninges, midbrain, pons, medulla oblongata, or spinal cord; d. Maintain clinical stability for at least 4 weeks before enrollment; 7. Anticancer treatment used before TIL collection: chemotherapy, immunocheckpoint inhibitors, other experimental drugs or local treatment for target lesions in the past 4 weeks, and systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effects (including thymosin and interferon) in the past 2 weeks, Received targeted drugs within the past 4 weeks (if the metabolic half-life of 5 targeted drugs is less than 4 weeks, the 5 half-life shall prevail); 8. Existence of acute or chronic infections, including: 1) A known history of positive human immunodeficiency virus (HIV) testing or a known history of acquired immunodeficiency syndrome; 2) Active tuberculosis infection (based on clinical symptoms, physical examination and/or imaging, and laboratory findings); 3) Active bacterial or fungal infections that require systemic treatment; 4) Hepatitis B surface antigen and/or hepatitis B e antigen positive patients; 5) Hepatitis C patients; 6) Patients with positive Treponema pallidum antibodies; 9. Those who have been vaccinated with novel coronavirus vaccine within 14 days before screening, or who have been vaccinated with live vaccine within 3 months before screening, or who plan to vaccinate with live vaccine during the test period; 10. Those who have undergone major organ surgery or experienced significant trauma within the first 4 weeks of screening, or who need to undergo elective surgery duri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Time-to-response;Duration of response;Overall Survival; | — |
Countries
China
Contacts
Public ContactJing Wang
The Affiliated Hospital of Qingdao University
Outcome results
None listed