Study of LY4152199 for B-cell Malignancies
This study is testing a drug called LY4152199 given through an IV (intravenous infusion) for people with certain types of B-cell malignancies (cancers that start in immune cells called B-cells) that have been treated before. These include follicular lymphoma or diffuse large B-cell lymphoma. The main goals are to find the safest and most effective dose of LY4152199 and to see how well it works. You may be able to join if you are 18 or older, have a good general health status (ECOG performance status of 0 or 1), and are expected to live at least 12 weeks. The study aims to enroll 215 participants. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is designed to find the best dose and measure the safety and effectiveness of LY4152199.
- What's involved
- Participants will receive LY4152199 by IV infusion. You may have the option to continue taking LY4152199 until the study ends.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for safety is measured from Cycle 1 Day 1 through Cycle 2 Day 8 (35 days).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07101328
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )
Recruiting
PHASE1Ages 18+InterventionalTreatmentEli Lilly and Company
~215 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY4152199 - IV
At a glance
Recruiting sites
18 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199
Measured over Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)
Conditions
Where it's being run
51 sites across 29 statesJapan4
New York3
Canada3
Germany3
Italy3
Spain3
Colorado2
Massachusetts2
Study leadership
- 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) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)