A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Purpose
The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.
Conditions
- Lymphoma, Non-Hodgkin
- B-cell Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Follicular
- Lymphoma, B-cell Marginal Zone
- Waldenstrom Macroglobulinemia
- Lymphoma, Mantle Cell
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma. - 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: - Participants with lymphoma 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. - 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 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed/refractory B-cell malignancy. Phase 1 Dose Optimization (Cohort B) Participants - Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL).
Exclusion Criteria
All Participants - Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL). - 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). - 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1: Dose Escalation (Cohort A) - DLBCL and FL |
Escalating doses of LY4152199 administered intravenously (IV) |
|
|
Experimental Phase 1: Dose Optimization (Cohort B1) - DLBCL |
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV |
|
|
Experimental Phase 1: Dose Optimization (Cohort B2) - FL |
Two or more doses of LY4152199 (evaluated during dose escalation) administered IV |
|
Recruiting Locations
Duarte, California 91010
Aurora, Colorado 80045-2559
Denver, Colorado 80218
New Haven, Connecticut 06520-8028
Chicago, Illinois 60637
Iowa City, Iowa 52242
Rochester, Minnesota 55905
New York, New York 10016
New York, New York 10021
New York, New York 10065
Nashville, Tennessee 37203
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
Study Contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
LillyTrials@Lilly.com