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

Recruiting now · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, B-cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-cell Marginal Zone, Waldenstrom Macroglobulinemia, Lymphoma, Mantle Cell

In brief

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.

Key facts

Study ID

NCT07101328

Run by

Eli Lilly and Company

People needed

215

Starts

2026-05-28

Expected to finish

2029-09-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Yale University School of Medicine - Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States (enrolling)
• Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• New York University (NYU) Clinical Cancer Center — New York, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Colorado Denver - School of Medicine - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• The Alfred Hospital — Melbourne, VIC, Australia
• Linear Clinical Research — Nedlands, Australia
• Lady Davis Institute for Medical Research Jewish General Hospital — Montreal, Canada
• University Health Network (UHN) - Princess Margaret Cancer Centre — Toronto, Canada
• BC Cancer - Vancouver — Vancouver, Canada
• Aarhus University Hospital — Aarhus, Denmark
• Center for Cancer and Organ Diseases - Rigshospitalet — Copenhagen, Denmark
• CHU de Lille - Hopital Claude Huriez — Lille, France
• AP-HP Hopital Saint-Louis — Paris, France
• Charite Universitaetsmedizin Berlin — Berlin, Germany
• LMU Klinikum Muenchen-Campus Grosshadern — München, Germany
• Universitaetsklinikum Muenster — Münster, Germany
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola — Bologna, Italy

Full record on ClinicalTrials.gov

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