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Clinical Trials in the USA / NCT07101328
Recruiting Phase 1

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

NCT07101328 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2026-05-28
Last updated
2026-09-08

Condition(s) studied

Lymphoma, Non-HodgkinB-cell LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, FollicularLymphoma, B-cell Marginal ZoneWaldenstrom MacroglobulinemiaLymphoma, Mantle Cell

Investigational drug(s) / intervention(s)

LY4152199 - IV

LY4152199 - IV: Administered by IV infusion

Study 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 malignancies. Participants will have the option to continue taking LY4152199 until the study ends.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
University of Colorado Denver - School of Medicine - Anschutz Medical Campus Aurora Colorado Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Yale University School of Medicine - Yale Cancer Center New Haven Connecticut Recruiting
The University of Chicago Medical Center (UCMC) Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
University of Kansas Cancer Center Kansas City Kansas Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan Recruiting
Mayo Clinic - Rochester Rochester Minnesota Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey Not Yet Recruiting
New York University (NYU) Clinical Cancer Center New York New York Recruiting
Weill Cornell Medicine New York New York Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center New York New York Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
University of Texas Southwestern Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Intermountain Healthcare Salt Lake City Utah Not Yet Recruiting
Swedish Cancer Institute (SCI) Seattle Washington Recruiting
Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin Recruiting
The Alfred Hospital Melbourne, VIC Australia Not Yet Recruiting
Linear Clinical Research Nedlands Australia Not Yet Recruiting
Lady Davis Institute for Medical Research Jewish General Hospital Montreal Canada Not Yet Recruiting
University Health Network (UHN) - Princess Margaret Cancer Centre Toronto Canada Not Yet Recruiting
BC Cancer - Vancouver Vancouver Canada Not Yet Recruiting
Aarhus University Hospital Aarhus Denmark Not Yet Recruiting
Center for Cancer and Organ Diseases - Rigshospitalet Copenhagen Denmark Not Yet Recruiting
CHU de Lille - Hopital Claude Huriez Lille France Not Yet Recruiting
AP-HP Hopital Saint-Louis Paris France Not Yet Recruiting
Charite Universitaetsmedizin Berlin Berlin Germany Not Yet Recruiting
LMU Klinikum Muenchen-Campus Grosshadern München Germany Not Yet Recruiting
Universitaetsklinikum Muenster Münster Germany Not Yet Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola Bologna Italy Not Yet Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Naples Italy Not Yet Recruiting
Istituto Clinico Humanitas Rozzano Italy Not Yet Recruiting
National Cancer Center Hospital East Chiba Japan Not Yet Recruiting
Okayama University Hospital Okayama Japan Recruiting

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07101328 on ClinicalTrials.gov ↗ ← All trials in the USA