A Study of LY4152199 in Participants With Previously Treated B-cell Cancers and Leukemia
NCT ID: NCT07101328
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
215 participants
INTERVENTIONAL
2025-12-31
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1A: Dose Escalation (Cohort A)
Escalating doses of LY4152199 administered intravenously (IV)
LY4152199 - IV
Administered by IV infusion
Phase 1A: Dose Optimization (Cohort B)
Two or more doses of LY4152199 (evaluated during dose escalation) administered SC
LY4152199 - SC
Administered by SC injection
Interventions
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LY4152199 - IV
Administered by IV infusion
LY4152199 - SC
Administered by SC injection
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
* Participants with chronic lymphocytic leukemia (CLL) must have assessable disease in blood or bone marrow by flow cytometry or immunohistochemistry.
* 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 1a Dose Escalation (Cohort A) Participants
\- Must have histologically confirmed relapsed/refractory B-cell malignancy.
Phase 1a Dose Optimization (Cohort B) Participants
\- Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed.
Exclusion Criteria
* 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). This exclusion criterion does not apply to participants seeking retreatment.
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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City of Hope
Duarte, California, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York University (NYU) Clinical Cancer Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Swedish Cancer Institute (SCI)
Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Peter MacCallum Cancer Centre
East Melbourne, , Australia
The Alfred Hospital
Melbourne, , Australia
Linear Clinical Research
Nedlands, , Australia
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, , Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, , Canada
Aarhus University Hospital
Aarhus, , Denmark
Center for Cancer and Organ Diseases - Rigshospitalet
Copenhagen, , Denmark
CHU de Lille - Hopital Claude Huriez
Lille, , France
AP-HP Hopital Saint-Louis
Paris, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
LMU Klinikum Muenchen-Campus Grosshadern
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
National Cancer Center Hospital East
Chiba, , Japan
Okayama University Hospital
Okayama, , Japan
Cancer Institute Hospital of JFCR
Tokyo, , Japan
Pratia MCM Krakow
Krakow, , Poland
AIDPORT Sp. z o.o.
Skorzewo, , Poland
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Other Identifiers
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J6N-MC-JUCA
Identifier Type: OTHER
Identifier Source: secondary_id
27701
Identifier Type: -
Identifier Source: org_study_id