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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT06649656
Eligibility Criteria:
Inclusion Criteria:
* The subjects voluntarily joined this study, signed an informed consent form, and showed good compliance;
* 18 years old ≤ 75 years old (calculated from the date of signing the informed consent form);
* Electrocorticogram (ECOG) score ranges from 0 to 1 points;
* Expected survival is greater than 12 weeks；
* Confirmed to have at least one measurable lesion according to RECIST 1.1 (solid tumor) or Lugano 2014 (lymphoma) criteria；
* Late stage malignant tumor subjects who have failed standard treatment or lack effective treatment；
* Women of childbearing age should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study; Men should agree to use effective contraceptive measures during the study period and for 6 months after the end of the study period.
Exclusion Criteria:
* Has experienced or currently has other malignant tumors within the past 5 years prior to the first use of medication;
* There are multiple factors that affect diseases related to intravenous injection and venous blood collection;
* The adverse reactions of previous anti-tumor treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score of ≤ 1;
* Individuals who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication;
* Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first administration;
* An arterial/venous thrombotic event occurred within 6 months prior to the first administration;
* Active viral hepatitis with poor control;
* Active syphilis infected individuals in need of treatment;
* History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;
* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
* Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy due to a history of hepatic encephalopathy;
* Previously experienced grade 3 or higher adverse reactions related to immunotherapy;
* Suffering from significant cardiovascular disease;
* Active or uncontrolled severe infections;
* Patients with renal failure requiring hemodialysis or peritoneal dialysis;
* History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
* Individuals with epilepsy who require treatment;
* Previously received treatment with similar anti-lag3 drugs.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06649656
Study Brief:
Protocol Section:
NCT06649656