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Phase IInterventional

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

Protocol: 2025P013946NCT: NCT07226843

Overview

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.

Eligibility

Ages18 Years and older
SexAll
Healthy VolunteersNo
Age GroupsAdult, Older Adult

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
Locations
Emory University Hospital Midtown
Emory Saint Joseph's Hospital
Winship Cancer Institute
View on ClinicalTrials.gov