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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05620693
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-70 (≥ 18, ≤ 70), regardless of gender;
2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
3. Late recurrent or metastatic soft tissue sarcoma confirmed by histopathology; Progress after receiving first-line treatment;
4. According to RECIST 1.1 standard, there are clear assessable lesions;
5. The expression of NY-ESO-1 in tumor tissue was confirmed by immunohistochemical staining; HLA-A configuration is 02/01;
6. Within 2 weeks before cell therapy, no antibody drugs were used;
7. ECOG score is 0-2;
8. The subject has no contraindication for peripheral blood collection;
9. The expected survival period is more than 3 months.
Exclusion Criteria:
1. People who have a history of allergy to any component in cell products;
2. The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of neutrophil ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
3. The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
4. According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)\<50% by echocardiography;
5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;
7. Grade 3 hypertension and poor blood pressure control after drug treatment;
8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;
9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;
10. There is uncontrolled active infection;
11. Have used any cell therapy products in recent 3 months;
12. Live vaccine inoculation within 4 weeks before enrollment;
13. HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers;
14. Subjects have a history of alcohol abuse, drug abuse or mental illness;
15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;
16. Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures;
17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05620693
Study Brief:
Protocol Section:
NCT05620693