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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT05616468
Eligibility Criteria:
Inclusion Criteria:
* 1\. Sign the written informed consent voluntarily;
* 2\. Age ≥ 18, ≤ 75, male or female;
* 3.Expected life ≥ 3 months
* 4\. The physical condition score of the Eastern Tumor Cooperative Organization (ECOG) is 0-2;
* 5.Biopsy sample or pathological wax slice test (within 1 year before signing the informed consent): target test positive
* 6\. According to RECIST v1.1 solid tumor evaluation criteria, there is at least one measurable lesion;
* 7\. Patients with recurrent/metastatic nasopharyngeal carcinoma who have received second-line or above system treatment failure in the past (Recurrence of nasopharyngeal carcinoma: nasopharyngeal carcinoma confirmed by pathology, after radical radiotherapy, the clinical tumor disappears completely, and after 6 months of treatment, local tumors with the same pathological type as the original tumor reappear; metastasis of nasopharyngeal carcinoma: tumor cells transfer from the primary site to distant organs through various ways, such as blood and lymph, and form tumor metastasis focus);
* 8\. It is possible to establish a single blood collection or venous blood collection channel, and there is no other blood cell separation contraindication;
* 9\. It has sufficient organ and bone marrow functions, as defined below
routine blood test
Neutrophil count (NEUT #) ≥ 1.0 × 10\^9/L
Platelet count (PLT) ≥ 80 × 10\^9/L
Hemoglobin concentration ≥ 90g/L
Liver function: subjects without liver metastasis
Aspartate aminotransferase (AST) ≤ 2.5 × Upper limit of normal value (ULN)
Alanine aminotransferase (ALT) ≤ 2.5 × Upper limit of normal value (ULN)
Total bilirubin (TBIL) ≤ 1.5 × ULN
Liver function: subjects with liver metastasis
Aspartate aminotransferase (AST) ≤ 5 × Upper limit of normal value (ULN)
Alanine aminotransferase (ALT) ≤ 5 × Upper limit of normal value (ULN)
Liver function: subjects with liver metastasis or Gilbert syndrome
Total bilirubin (TBIL) ≤ 2 × ULN
renal function
Creatinine clearance rate (CCR) ≥ 50mL/min
Coagulation function
International normalized ratio (INR) ≤ 1.5 × ULN
Activated partial thromboplastin event (APTT) ≤ 1.5 × ULN
* 10\. Toxic side effects left by early anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) ≤ Level 1 (CTCAE5.0);
* 11\. During the study period and within 6 months after the last administration, subjects with fertility (male or female) must take effective medical contraceptive measures. Female subjects of childbearing age must have a pregnancy test within 72 hours before the first administration, and the result is negative.
Exclusion Criteria:
* 1\. Active central nervous system metastasis (except those that are stable after treatment);
* 2\. HIV positive or HBsAg positive, HBV DNA copy number is positive (quantitative test ≥ 1000 cps/ml) or HCV antibody is positive and HCV RNA is positive;
* 3\. Those who have mental or psychological diseases and cannot cooperate with the treatment and efficacy evaluation;
* 4\. Subjects with severe autoimmune diseases and long-term application of immunosuppressants;
* 5\. There is active infection or uncontrollable infection requiring systemic treatment within 14 days before signing the informed consent form;
* 6\. Any unstable systemic disease (including but not limited to): Active infection (except local infection);
Unstable angina pectoris;
Cerebrovascular ischemia or cerebrovascular accident (within 6 months before screening);
Myocardial infarction (within 6 months before screening);
Congestive heart failure (New York Heart Association \[HYHA\] classification ≥ Ⅲ);
Serious arrhythmia requiring drug treatment;
Heart disease needs treatment or hypertension is out of control after treatment (blood pressure\>160mmHg/100mmHg);
* 7\. Complicated with dysfunction of lung, brain, kidney and other important organs;
* 8\. Subjects had undergone major surgery or severe trauma within 4 weeks before signing the informed consent form, or were expected to undergo major surgery during the study period.
* 9\. Subjects received the last radiotherapy or anti-tumor treatment (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before signing the informed consent form;
* 10\. The subject currently suffers from or has suffered from other malignant tumors that cannot be cured within 3 years, except for cervical cancer or skin basal cell cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
* 11\. Have received T cells (including CAR-T and TCR-T) modified by chimeric antigen receptor within half a year before signing the informed consent form;
* 12\. Graft versus host disease (GVHD)
* 13\. Subjects who were receiving systemic steroid treatment before signing the informed consent form and who were judged by the investigator to need long-term use of systemic steroid treatment during the treatment period (except for inhalation or local use); And subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhalation or local use);
* 14\. Serious allergy or allergy history
* 15\. Subjects requiring anticoagulation treatment
* 16\. Pregnant or lactating women, or have a pregnancy plan within six months (for both men and women);
* 17\. The investigator believes that there are other reasons that cannot be included in the treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05616468
Study Brief:
Protocol Section:
NCT05616468