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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT05828459
Eligibility Criteria:
Main Inclusion Criteria:
* Histologically or cytologically confirmed relapsed/refractory hematological malignancy or advanced/metastatic solid cancer
* Measurable disease
* Have had all available therapeutic standards for their disease
* Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy
* ECOG performance status ≤ 1
* Life expectancy \> 3 months as assessed by the investigator
* Acceptable clinical lab results
Main Exclusion Criteria:
* Systemic steroids at a daily dose of \> 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed
* Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
* Within 4 weeks of major surgery
* Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months
* Prior solid organ transplant
* Primary or secondary immune deficiency
* Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment
* Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Clinically significant disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05828459
Study Brief:
Protocol Section:
NCT05828459