RecruitingRecruiting
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
NCT07101328 · Eli Lilly and Company
In plain English
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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
About this study
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.
Eligibility criteria
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
Enrollment target: 215 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-28
Estimated completion: 2029-09
Last updated: 2026-07-10
Interventions
Drug: LY4152199 - IV
Primary outcomes
- • Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199 (Cycle 1 Day 1 through Cycle 2 Day 8 (35 days))
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (50)
City of HopeRecruiting
Duarte, California, United States
University of Colorado Denver - School of Medicine - Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Yale University School of Medicine - Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
The University of Chicago Medical Center (UCMC)Recruiting
Chicago, Illinois, United States
University of IowaRecruiting
Iowa City, Iowa, United States
University of Kansas Cancer CenterNot Yet Recruiting
Kansas City, Kansas, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteNot Yet Recruiting
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer CenterNot Yet Recruiting
Ann Arbor, Michigan, United States
Mayo Clinic - RochesterRecruiting
Rochester, Minnesota, United States
Rutgers Cancer Institute of New JerseyNot Yet Recruiting
New Brunswick, New Jersey, United States
New York University (NYU) Clinical Cancer CenterRecruiting
New York, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States
University of Pennsylvania Abramson Cancer CenterNot Yet Recruiting
Philadelphia, Pennsylvania, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
University of Texas SouthwesternNot Yet Recruiting
Dallas, Texas, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Intermountain HealthcareNot Yet Recruiting
Salt Lake City, Utah, United States
Swedish Cancer Institute (SCI)Not Yet Recruiting
Seattle, Washington, United States
Froedtert Hospital and the Medical College of WisconsinNot Yet Recruiting
Milwaukee, Wisconsin, United States
The Alfred HospitalNot Yet Recruiting
Melbourne, VIC, Australia
Linear Clinical ResearchNot Yet Recruiting
Nedlands, Australia
Lady Davis Institute for Medical Research Jewish General HospitalNot Yet Recruiting
Montreal, Canada
University Health Network (UHN) - Princess Margaret Cancer CentreNot Yet Recruiting
Toronto, Canada
BC Cancer - VancouverNot Yet Recruiting
Vancouver, Canada
Aarhus University HospitalNot Yet Recruiting
Aarhus, Denmark
Center for Cancer and Organ Diseases - RigshospitaletNot Yet Recruiting
Copenhagen, Denmark
CHU de Lille - Hopital Claude HuriezNot Yet Recruiting
Lille, France
AP-HP Hopital Saint-LouisNot Yet Recruiting
Paris, France
Charite Universitaetsmedizin BerlinNot Yet Recruiting
Berlin, Germany
LMU Klinikum Muenchen-Campus GrosshadernNot Yet Recruiting
München, Germany
Universitaetsklinikum MuensterNot Yet Recruiting
Münster, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant OrsolaNot Yet Recruiting
Bologna, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. PascaleNot Yet Recruiting
Naples, Italy
Istituto Clinico HumanitasNot Yet Recruiting
Rozzano, Italy
National Cancer Center Hospital EastNot Yet Recruiting
Chiba, Japan
Okayama University HospitalNot Yet Recruiting
Okayama, Japan
The Cancer Institute Hospital of JFCRNot Yet Recruiting
Tokyo, Japan
Pratia MCM KrakowNot Yet Recruiting
Krakow, Poland
AIDPORT Sp. z o.o.Not Yet Recruiting
Skorzewo, Poland
Seoul National University HospitalNot Yet Recruiting
Seoul, South Korea
Asan Medical CenterNot Yet Recruiting
Seoul, South Korea
Hospital Universitario Vall d'HebronNot Yet Recruiting
Barcelona, Spain
Institut Catala d'Oncologia - L'HospitaletNot Yet Recruiting
Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez DiazNot Yet Recruiting
Madrid, Spain
Leeds Teaching Hospitals NHS TrustNot Yet Recruiting
Leeds, United Kingdom
Oxford University Hospitals NHS Foundation TrustNot Yet Recruiting
Oxford, United Kingdom