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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT07101328
Eligibility Criteria:
Inclusion Criteria:
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.
* Participants with select tumor types must have measurable or assessable disease as defined below:
* Must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.
* Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing.
* Participants with chronic lymphocytic leukemia (CLL) must have assessable disease in blood or bone marrow by flow cytometry or immunohistochemistry.
* Must be able to comply with inpatient/outpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.
* Must have adequate organ function.
Phase 1a Dose Escalation (Cohort A) Participants
\- Must have histologically confirmed relapsed/refractory B-cell malignancy.
Phase 1a Dose Optimization (Cohort B) Participants
\- Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed.
Exclusion Criteria:
All Participants
* Known or suspected central nervous system (CNS) involvement by systemic lymphoma.
* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.
* Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.
* Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.
* Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).
* Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.
* History of autoimmune disease
* Significant cardiovascular disease
* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process
* Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).
* Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
* Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody). This exclusion criterion does not apply to participants seeking retreatment.
* Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.
* Known hypersensitivity to any component or excipient of LY4152199.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07101328
Study Brief:
Protocol Section:
NCT07101328