Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT02457650
Eligibility Criteria:
* Inclusion Criteria:
1. Must be pathology or cytology confirmed cancer patients with age of one year old and over；
2. Must be HLA-A2 positive, and cancer tissues express NY-ESO-1；
3. There is at least one measurable disease: diameter ≥20mm or spiral CT≥10mm；
4. Willing to sign a durable power of attorney；
5. Able to understand and sign the Informed Consent Document；
6. Performance status：ECOG 0-2；
7. Life expectancy：More than 3 months；
8. Patients must be willing to practice birth control for four months after receiving a lymphodepleting preconditioning regimen；
9. Patients with no pregnancy and lactation；
10. Hematopoietic： (1) Absolute neutrophil count \> 1000/mm3 without support of filgrastim； (2) Platelet count \> 100,000/mm3； (3) Hemoglobin \> 8.0 g/dL； (4) lymphocyte count \>500/mm3； (5) WBC \> 3,000/mm3；
11. Chemistry： (1) AST and ALT \< 2.5 times upper limit of normal； (2) Serum creatinine≤1.6 mg/dl； (3) Bilirubin ≤1.5 mg/dL（3.0 mg/dL in patients with Gilbert's syndrome）；
12. Seronegative for hepatitis B and C viruses；
13. Seronegative for human immunodeficiency virus (HIV) antibody；
14. More than four weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients' toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria；
15. Six weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow antibody levels to decline. Patients who have previously received any anti-CTLA4 antibody and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies.
* Exclusion Criteria:
1. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)；
2. Active systemic infections；
3. Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system；
4. Concurrent use of systemic steroids；
5. History of severe immediate hypersensitivity reaction to any of the agents used in this study；
6. There are obvious dysfunctions in heart , liver，kidney and other vital organs
7. T cell lymphoma and leukemia patients；
8. HIV positive；
9. History of coronary revascularization or ischemic symptoms；
10. Documented Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45 percent tested in patients with: Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block；
11. Documented forced expiratory volume 1 (FEV1) less than or equal to 60 percent predicted tested in patients with a prolonged history of cigarette smoking (20 pk/yrs of smoking) or symptoms of respiratory dysfunction；
12. Bronchial lesions (probably shifted obstructive pneumonia or intracranial hemorrhage risk)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT02457650
Study Brief:
Protocol Section:
NCT02457650