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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT05143151
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old (≥18 years old, ≤75 years old), no gender limit;
2. The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
3. Unresectable, locally advanced recurrence or metastatic pancreatic cancer diagnosed by histopathological examination; according to the American Joint Committee on Cancer (AJCC) TNM staging system (2017 version 8), diagnosed as stage III or IV pancreatic cancer ；
4. According to the RECIST 1.1 standard, there are clear measurable and evaluable lesions;
5. The tumor tissue was confirmed by immunohistochemical staining, and CD276 expression was positive;
6. The subject must have received first-line treatment;
7. The subject must be unsuitable for radical treatment, such as radical chemotherapy and/or surgery/immune checkpoint inhibitors, or refuse surgical resection
8. Within 2 weeks before cell therapy, have not received antibody drug treatment;
9. The ECOG score is 0-2 points;
10. The subject has no contraindications for peripheral blood apheresis;
11. The expected survival time is more than 3 months
Exclusion Criteria:
1. Those who have a history of allergies to any of the ingredients in cell products;
2. Routine blood examinations have the following conditions: WBC≦1×109/L, absolute centrioles ANC≦0.5×109/L, absolute lymphocyte value ALC≦0.5×109/L, PLT≦25×109/L;
3. The following conditions in laboratory tests include, but are not limited to, serum total bilirubin ≥ 1.5 mg/dl; serum ALT or AST greater than 2.5 times the upper limit of normal; blood creatinine ≥ 2.0 mg/dl;
4. According to the New York Heart Association (NYHA) cardiac function classification standards, patients with grade III or IV cardiac insufficiency; or echocardiographic examination of left ventricular ejection fraction (LVEF) \<50%;
5. Abnormal lung function, blood oxygen saturation in indoor air \<92%;
6. Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina pectoris, or other serious clinical heart diseases within 12 months before enrollment;
7. High blood pressure level 3 and poor blood pressure control with medication;
8. Previously suffering from head injury, disturbance of consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
9. Patients with autoimmune diseases, immunodeficiencies, or other patients who need immunosuppressive therapy;
10. There is an uncontrolled active infection;
11. Have used any CAR-T cell products or other genetically modified T cell therapies before;
12. Live vaccination within 4 weeks before enrollment;
13. HIV, HBV, HCV and TPPA/RPR infected persons, and HBV carriers;
14. The subject has a history of alcoholism, drug abuse or mental illness;
15. The subject has participated in any other clinical research within 3 months before joining this clinical research;
16. Female subjects who have any of the following conditions: a) are pregnant/lactating; or b) have a pregnancy plan during the trial period; or c) have fertility and cannot take effective contraceptive measures;
17. The researcher believes that the subject has other conditions that are not suitable for participating in this research
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05143151
Study Brief:
Protocol Section:
NCT05143151