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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04806035
Eligibility Criteria:
Inclusion Criteria:
* B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy
* Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)
* Treatment Status:
1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT
3. CLL subjects: relapsed to or refractory after at least two prior standard therapies
* Measurable disease defined as:
1. NHL (including SLL): at least 1 measurable disease lesion \> 1.5 centimeters (cm)
2. CLL: at least 1 measurable disease lesion
Exclusion Criteria:
* Prior therapy with any agent blocking the CD47/SIRPĪ± pathway or any previous CD19 targeting therapy,
* Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Cycle 1 Day 1.
* Prior autologous stem cell transplant (SCT) within 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04806035
Study Brief:
Protocol Section:
NCT04806035