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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT07044050
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy
* with evaluable disease
* with adequate biological parameters at baseline
* ECOG performance status ≤1
* life expectancy \>3 months as assessed by the investigator
Exclusion Criteria:
* Receive concomitantly any antitumor-directed drug therapy
* Any vaccination with live virus vaccines before or during treatment
* With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
* Major surgery within 3 weeks
* With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
* Ongoing immune-related tocivities or adverse events grade \>1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
* Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
* Primary or secondary immune deficiency
* Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
* Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV
* Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months
* Dementia or altered mental status that would prohibit informed consent
* Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07044050
Study Brief:
Protocol Section:
NCT07044050