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NCT Number: NCT07226843

A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers

The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.

Recruiting

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Key information

Conditions

Lymphoma, Non-Hodgkin's Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Nantes - Hotel-Dieu, Nantes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy:
  • Diffuse large B-cell lymphoma - not otherwise specified
  • High-grade B-cell lymphoma
  • Diffuse large B-cell lymphoma - transformed from indolent lymphomas
  • Follicular large B-cell lymphoma
  • Follicular lymphoma
  • Other non-Hodgkin lymphoma
  • Has measurable disease
  • Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy

Exclusion criteria

  • Has an active second cancer
  • Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.
  • Has known Cytomegalovirus infection. Participants with negative status are eligible
  • Has known hepatitis B or C infection or uncontrolled HIV
  • Has known significant heart disease

Treatment and study plan

LY4584180

Drug

administered orally

Rituximab

Drug

administered through IV infusion

Primary outcomes

  1. Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

    Time frame: Baseline up to Day 28

    Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

  2. Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline up to 3 Years

    Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  3. To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)

    Time frame: Baseline up to 3 Years

    To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180

    Time frame: Baseline to Day 8

    PK: Cmax of LY4584180

  2. PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180

    Time frame: Baseline to Day 8

    PK: AUC versus time curve of LY4584180

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Nov 12, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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