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:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT07002502
Eligibility Criteria:
Inclusion Criteria:
Patients with a history of other malignant diseases within the past 5 years, except for curatively treated skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, which, in the judgment of the investigator, may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment; Clinically significant (i.e., active) cardiovascular disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months; Patients currently receiving immunosuppressive therapy; Known active major infections, or significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator; Patients with hypersensitivity to any component of the investigational drugs; History of immunodeficiency, including positive HIV test results or other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy; Other conditions deemed unsuitable for enrollment by the investigator.
Exclusion Criteria:
Patients with a history of any other malignant diseases within the past 5 years are excluded, except for curatively treated skin cancer and cervical carcinoma in situ.
Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders are excluded if, in the judgment of the investigator, these conditions may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment.
Clinically significant (active) cardiovascular disease is excluded, including symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.
Patients currently receiving immunosuppressive therapy are excluded. Known active major infections are excluded, as are significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator.
Patients with hypersensitivity to any component of the investigational drugs are excluded.
History of immunodeficiency is excluded, including positive HIV test results, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy.
Other conditions deemed unsuitable for enrollment by the investigator are excluded.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07002502
Study Brief:
Protocol Section:
NCT07002502