ClinicalTrials.gov record NCT07101328

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationAustralia, Canada, Denmark, France, Germany, Italy, Japan, Poland, South Korea, Spain, United Kingdom, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1, first-in-human trial tests the drug LY4152199 given by IV to find the best dose and measure safety and early signs of activity in adults with previously treated B‑cell malignancies (for example, diffuse large B‑cell lymphoma or follicular lymphoma). The study starts with dose escalation and then moves to dose-optimization groups. Participants may have the option to continue on LY4152199 until the study ends.

What it is studying. Whether LY4152199 can be safely given, what dose should be used, how the drug behaves in the body (pharmacokinetics), and early measures of tumor response in people with previously treated B‑cell malignancies.

What the researchers hope to learn. To identify a recommended dose and characterize safety and tolerability; to measure pharmacokinetics (AUC, Cmax); and to collect preliminary response and time-to-event outcomes (overall response rate, duration of response, time to response, progression-free survival).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • LY4152199 - IV

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive the study drug LY4152199 by intravenous (IV) infusion as part of a Phase 1 dose‑finding and dose‑optimization plan. Study visits include clinic visits for infusions, blood sampling for drug measurements and safety monitoring, and disease assessments done using disease‑specific response criteria. Participants who continue to meet study requirements may keep receiving LY4152199 until the study ends. Participants may be followed for response, duration of response, and disease progression for up to about four years.

How the study is structured. First-in-human Phase 1 interventional trial. Participants receive LY4152199 by intravenous infusion. The study begins with a dose-escalation stage to find a tolerated dose, then moves to dose-optimization cohorts for specific lymphoma types; allocation is randomized and there is no masking.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Australia, Canada, Denmark, France, Germany, Italy, Japan, Poland, South Korea, Spain, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 28, 2026
Primary completion
April 2027 (estimated)
Study completion
September 2029 (estimated)
Target enrollment
215 participants (estimated)
Last updated on registry
Oct 8, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Eli Lilly and Company

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (51)

  • City of HopeRecruiting

    Duarte, California, 91010 · United States

  • University of Colorado Denver - School of Medicine - Anschutz Medical CampusRecruiting

    Aurora, Colorado, 80045-2559 · United States

  • Colorado Blood Cancer InstituteRecruiting

    Denver, Colorado, 80218 · United States

  • Yale University School of Medicine - Yale Cancer CenterRecruiting

    New Haven, Connecticut, 06520-8028 · United States

  • The University of Chicago Medical Center (UCMC)Recruiting

    Chicago, Illinois, 60637 · United States

  • University of IowaRecruiting

    Iowa City, Iowa, 52242 · United States

  • University of Kansas Cancer CenterRecruiting

    Kansas City, Kansas, 66160 · United States

  • Massachusetts General HospitalRecruiting

    Boston, Massachusetts, 02114 · United States

  • Dana-Farber Cancer InstituteRecruiting

    Boston, Massachusetts, 02215 · United States

  • University of Michigan Comprehensive Cancer CenterRecruiting

    Ann Arbor, Michigan, 48109 · United States

Terms used on this page · explanations by MedicalUpdates.ai

ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Dose Escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
Cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
prior therapy
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
Adverse Events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
chimeric antigen receptor
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
Sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
bispecific antibody
An engineered antibody that attaches to two targets at once, often linking an immune cell to a diseased cell so the immune cell can attack it.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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