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NCT07101328

PHASE1

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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 lymphoma.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

215

Start Date

2026-06

Completion Date

2029-03

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Lymphoma, Non-Hodgkin B-cell Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular

Interventions

DRUG

LY4152199 - IV

Administered by IV infusion

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. * 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. * Must have failed or were intolerant to at least 2 prior lines of therapy appropriate for available treatment for the specific B-cell malignancy 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.

Locations (50)

City of Hope

Duarte, California, United States

University of Colorado Denver - School of Medicine - Anschutz Medical Campus

Aurora, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

New York University (NYU) Clinical Cancer Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Intermountain Healthcare

Salt Lake City, Utah, United States

Swedish Cancer Institute (SCI)

Seattle, Washington, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Italy

Istituto Clinico Humanitas

Rozzano, Italy

National Cancer Center Hospital East

Chiba, Japan

Okayama University Hospital

Okayama, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Pratia MCM Krakow

Krakow, Poland

AIDPORT Sp. z o.o.

Skorzewo, Poland

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Institut Catala d'Oncologia - L'Hospitalet

Barcelona, Spain

South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

Madrid, Spain

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (50)