Tests LY4152199 in adults with previously treated B-cell lymphoma
Tests the drug LY4152199 in adults with B-cell lymphoma that has returned after treatment.
Plain-language title generated from the registry record
Registry title: A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Key facts
- Where
- Berlin, München, and Münster, GermanySee the 3 sites
- Phase
- Phase 1
Where in Germany
- Charité - Universitaetsmedizin BerlinBerlin, GermanyNot yet recruiting
- LMU Klinikum Muenchen-Campus GrosshadernMünchen, GermanyNot yet recruiting
- Universitaetsklinikum MuensterMünster, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07101328EU 2025-524180-20-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies
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.
Inclusion: 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: 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; Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF); Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody); Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease; 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; Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins); Known hypersensitivity to any component or excipient of LY4152199; 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); All Participants; Known or suspected central nervous system (CNS) involvement by systemic lymphoma; Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.