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A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )

RecruitingPhase 1Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ)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 (ร—) 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 (โ‰ฅ) 5000 cells per microliter (ฮผL). * 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.
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What it tests

  • LY4152199 - IV
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Where

51 sites
City of Hope
Duarte, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, United States
Colorado Blood Cancer Institute
Denver, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, United States
The University of Chicago Medical Center (UCMC)
Chicago, United States
University of Iowa
Iowa City, United States
University of Kansas Cancer Center
Kansas City, United States
Massachusetts General Hospital
Boston, United States

โ€ฆand 43 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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