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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT06182735
Eligibility Criteria:
Inclusion Criteria:
1. Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
2. Age 18 to 75 years.
3. Patients with advanced clear cell renal cell carcinoma confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
4. Archival and/or fresh tumor tissue samples are required.
5. At least one measurable lesion at baseline per RECIST version 1.1.
6. ECOG 0-1 points.
7. The expected survival time is more than 12 weeks.
8. The functions of important organs are basically normal: Hematopoietic function: neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L; Renal function: creatinine clearance of ≥60 mL/min.; Liver function: ALT and AST≤2.5×ULN (≤5 × ULN for patients with liver metastases); Total bilirubin≤1.5×ULN. Coagulation INR \< 1.7.
9. Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
Exclusion Criteria:
1. Pregnant or lactating female subjects.
2. Pregnant or lactating female subjects.
3. Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS).
4. Active infection or uncontrollable infection.
5. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
6. Having a history of any mental illness, including dementia, altered mental status, which may affect informed consent and the understanding of the subject by the relevant questionnaire.
7. Have a serious uncontrollable illness that may affect the subject receiving treatment for this study.
8. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
9. Subjects who are using systemic steroids or steroid inhalers for treatment.
10. Use of anti-CD70 therapy or cell therapy within the previous 3 months.
11. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
12. Subjects allergic to immunotherapy or related drugs.
13. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
14. Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
15. Earnestly received or organ transplantation or preparing to receive organ transplants.
16. Other investigators deem it unsuitable to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06182735
Study Brief:
Protocol Section:
NCT06182735