A Study of LY4152199 in Participants With Previously Treated B-cell Cancers (BAF_FRontier-1 )
BAF_FRontier-1
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
2 other identifiers
interventional
215
12 countries
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
Typical duration for phase_1
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
Study Completion
Last participant's last visit for all outcomes
March 1, 2029
March 20, 2026
March 1, 2026
10 months
July 28, 2025
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199
Approximately 35 days
Secondary Outcomes (7)
Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199
Baseline up to approximately 91 weeks
Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199
Baseline up to approximately 91 weeks
Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR)
Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1 - Duration of Response (DOR)
Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1- Time to Response (TTR)
Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
- +2 more secondary outcomes
Study Arms (3)
Phase 1: Dose Escalation (Cohort A DLBCL and FL)
EXPERIMENTALEscalating doses of LY4152199 administered intravenously (IV)
Phase 1: Dose Optimization (Cohort B1 DLBCL)
EXPERIMENTALTwo or more doses of LY4152199 (evaluated during dose escalation) administered IV
Phase 1: Dose Optimization (Cohort B2 FL)
EXPERIMENTALTwo or more doses of LY4152199 (evaluated during dose escalation) administered IV
Interventions
Administered by IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
City of Hope
Duarte, California, 91010, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, 80045-2559, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
New York University (NYU) Clinical Cancer Center
New York, New York, 10016, United States
Weill Cornell Medicine
New York, New York, 10021, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
University of Texas Southwestern
Dallas, Texas, 75244, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Intermountain Healthcare
Salt Lake City, Utah, 84111, United States
Swedish Cancer Institute (SCI)
Seattle, Washington, 98104, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Alfred Hospital
Melbourne, VIC, 3004, Australia
Linear Clinical Research
Nedlands, 6009, Australia
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, H3T 1E2, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, M5G 1Z5, Canada
BC Cancer - Vancouver
Vancouver, V5Z 1L3, Canada
Aarhus University Hospital
Aarhus, N 8200, Denmark
Center for Cancer and Organ Diseases - Rigshospitalet
Copenhagen, 2100, Denmark
CHU de Lille - Hopital Claude Huriez
Lille, 59037, France
AP-HP Hopital Saint-Louis
Paris, 75010, France
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
LMU Klinikum Muenchen-Campus Grosshadern
München, 80336, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, 40138, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Okayama University Hospital
Okayama, 700-8558,, Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Pratia MCM Krakow
Krakow, 30-727, Poland
AIDPORT Sp. z o.o.
Skorzewo, 60-185, Poland
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040, Spain
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
March 1, 2029
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share