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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04809467
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
* Willingness to undergo biopsy
* At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)
* Relapsed, progressive, or refractory NHL or CLL
* For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)
* ECOG-PS 0 - 2
* LVEF ≥ 50%
* Adequate renal, hepatic, bone marrow function
Exclusion Criteria:
* Any other histological type of lymphoma
* Primary or secondary CNS lymphoma
* Anticancer and/or investigational therapy within the past 30 days or 5 half-lives
* Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1
* Previous treatment with CD19-targeted therapy or PI3K inhibitors
* Clinically significant cardiac disease
* Other malignancy within the past 3 years
* Active graft-versus-host disease
* Stroke or intracranial hemorrhage within the past 6 months
* Chronic or current active infectious disease
* Positive virus serology for HCV, HBV, HIV
* Currently pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04809467
Study Brief:
Protocol Section:
NCT04809467