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NCT07101328RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
215 (estimated)
First submitted
28 Jul 2025
Start date
28 May 2026
Primary completion date
Apr 2027
Lead sponsor
Eli Lilly and Company
NCT number
NCT07101328
EU CT number
2025-524180-20-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 215
  • From 28 May 2026 to the primary completion date, Apr 2027
  • 51 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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.

Lab values

  • 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).

Other

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Alfred Hospital
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Melbourne, VICAustraliaRecruiting
Linear Clinical Research
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NedlandsAustraliaRecruiting
Lady Davis Institute for Medical Research Jewish General Hospital
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MontrealCanadaNot yet recruiting
University Health Network UHN Princess Margaret Cancer Centre
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TorontoCanadaNot yet recruiting
BC Cancer - Vancouver
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VancouverCanadaNot yet recruiting
Charité - Universitaetsmedizin Berlin
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BerlinGermanyNot yet recruiting
LMU Klinikum Muenchen-Campus Grosshadern
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MünchenGermanyNot yet recruiting
Universitaetsklinikum Muenster
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MünsterGermanyNot yet recruiting
Aarhus University Hospital
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AarhusDenmarkNot yet recruiting
Center for Cancer and Organ Diseases - Rigshospitalet
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CopenhagenDenmarkNot yet recruiting
Hospital Universitario Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Institut Catala d'Oncologia - L'Hospitalet
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BarcelonaSpainNot yet recruiting
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
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MadridSpainNot yet recruiting
CHU de Lille - Hopital Claude Huriez
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LilleFranceNot yet recruiting
AP-HP Hôpital Saint Louis
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ParisFranceNot yet recruiting
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomNot yet recruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomNot yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
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BolognaItalyNot yet recruiting
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
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NaplesItalyNot yet recruiting
Istituto Clinico Humanitas
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RozzanoItalyNot yet recruiting
National Cancer Center Hospital East
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ChibaJapanNot yet recruiting
Okayama University Hospital
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OkayamaJapanRecruiting
National Cancer Center Hospital
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TokyoJapanNot yet recruiting
The Cancer Institute Hospital of JFCR
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TokyoJapanRecruiting
Asan Medical Center
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SeoulSouth KoreaNot yet recruiting
Seoul National University Hospital
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SeoulSouth KoreaNot yet recruiting
Pratia MCM Krakow
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KrakowPolandNot yet recruiting
Aidport sp z o.o.
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SkorzewoPolandNot yet recruiting
University Of Michigan Comprehensive Cancer Center
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Ann ArborUnited StatesRecruiting
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
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AuroraUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
The University of Chicago Medical Center (UCMC)
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ChicagoUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
University of Texas, Southwestern
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DallasUnited StatesRecruiting
Colorado Blood Cancer Institute
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DenverUnited StatesRecruiting
City of Hope
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DuarteUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of Iowa
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Iowa CityUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
Froedtert Hospital and the Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesNot yet recruiting
Yale University School of Medicine - Yale Cancer Center
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New HavenUnited StatesRecruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
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New YorkUnited StatesRecruiting
Weill Cornell Medicine
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New YorkUnited StatesRecruiting
New York University (NYU) Clinical Cancer Center
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New YorkUnited StatesRecruiting
University of Pennsylvania/Abramson Cancer Center
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PhiladelphiaUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
Intermountain Healthcare
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Salt Lake CityUnited StatesNot yet recruiting
Swedish Cancer Institute (SCI)
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SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.