Recruiting
Phase 1

LY4152199

Sponsor:

Eli Lilly and Company

Code:

NCT07101328

Conditions

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Follicular

Lymphoma, B-cell Marginal Zone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY4152199 - IV

Study Details

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

Conditions

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Follicular

Lymphoma, B-cell Marginal Zone

Study ID

NCT07101328

Start date

May 28, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

215 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1: Dose Escalation (Cohort A) - DLBCL and FL

Escalating doses of LY4152199 administered intravenously (IV)

experimental: Phase 1: Dose Optimization (Cohort B1) - DLBCL

Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

experimental: Phase 1: Dose Optimization (Cohort B2) - FL

Two or more doses of LY4152199 (evaluated during dose escalation) administered IV

Interventions

LY4152199 - IV

Administered by IV infusion

Primary outcome measure

  • Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199 [ Time Frame: Cycle 1 Day 1 through Cycle 2 Day 8 (35 days) ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

University of Colorado Denver - School of Medicine - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045-2559

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Yale University School of Medicine - Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520-8028

The University of Chicago Medical Center (UCMC)

Recruiting

Chicago, Illinois, United States, 60637

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

New York University (NYU) Clinical Cancer Center

Recruiting

New York, New York, United States, 10016

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75244

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Froedtert Hospital and the Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • B- cell activating factor receptor (BAFFR)
  • Bispecific antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.