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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT07240857
Eligibility Criteria:
Inclusion Criteria
1. understanding of this study and voluntarily signs the informed consent form;
2. Aged ≥ 18 years;
3. Expected survival time of at least 3 months;
4. non-metastatic CRPC (nmCRPC) (local recurrence) or metastatic CRPC (mCRPC)；
5. continue GnRH analog therapy；
6. at least one evaluable lesion per RECIST 1.1;
7. Has received at least one type of novel endocrine therapy；
8. PSMA positive expression rate \> 10%;
9. Eastern Cooperative Oncology Group (ECOG) 0-1;
10. Well organ function
11. Left Ventricular Ejection Fraction (LVEF) \> 50%;
12. Oxygen saturation \> 92% without oxygen supplementation;
13. agree to use effective contraceptive measures
Exclusion Criteria
1. Presence of brain metastasis;
2. Organ transplantation or pending organ transplantation;
3. Uncontrolled large-volume serous cavity effusions；
4. A history of autoimmune diseases；
5. A history of receiving other cell therapies or genetically modified cell therapies (e.g., TCR-T therapy, CAR-T therapy);
6. A history of receiving any PSMA-targeted therapy;
7. Requirement for steroid therapy (except for physiological replacement therapy);
8. A history of receiving immunotherapies;
9. A history of clinically significant central nervous system (CNS) diseases (either past or present at screening);
(12) A history of other untreated malignant tumors; (13) Participants with severe cardiovascular diseases; (14) Active infectious diseases; (15) Active hepatitis B or hepatitis C virus infection; (16) Active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection (17) Intolerance or allergy to cyclophosphamide or fludarabine chemotherapeutic drugs; (18) No accessible injection sites; (19) Assessment by the investigator that the participant is unsuitable for participation in this clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07240857
Study Brief:
Protocol Section:
NCT07240857