New therapy dose test for people with prior B-cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial investigates LY4152199 given by IV to adults with previously treated B-cell malignancies, including follicular lymphoma and diffuse large B-cell lymphoma. The goal is to identify a tolerable dose while collecting signals of safety and preliminary efficacy, with participants potentially continuing the drug until the study ends. Key eligibility requires measurable disease in most cases, good performance status, and adequate organ function. The study is sponsored by Eli Lilly and involves sites in California and Colorado.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• University of Colorado Denver - School of Medicine - Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Yale University School of Medicine - Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• The University of Chicago Medical Center (UCMC)
  Chicago, Illinois, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.