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LY4584180 with rituximab for adults with previously treated B‑cell lymphomas

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

Phase 1 Interventional Eli Lilly and Company · NCT07226843

This trial will test LY4584180 together with rituximab in adults with previously treated B‑cell lymphomas to see if it is safe, reaches useful levels in the blood, and can help control the disease.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations45 sites (Scottsdale, Arizona and 44 other locations)
Trial IDNCT07226843 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open-label study of the investigational agent LY4584180 given with rituximab in adults who have received prior systemic therapy for B‑cell non‑Hodgkin lymphomas. The trial focuses on safety, how the drug is processed in the body (pharmacokinetics), and early signs of anti‑tumor activity, with each participant followed for about nine months or longer including screening. Eligible participants must have measurable disease, have recovered from prior therapy, and typically have had at least two prior lines of systemic treatment or be ineligible for available therapy. Key exclusions include active second cancers, active CNS involvement by lymphoma, or known cytomegalovirus infection, and enrollment occurs at selected U.S. cancer centers.

Who should consider this trial

Good fit: Adults with diffuse large B‑cell, high‑grade B‑cell, transformed, follicular large B‑cell, follicular lymphoma, or other non‑Hodgkin B‑cell lymphomas who have measurable disease and have received at least two prior systemic therapies or are not eligible for available therapy may qualify.

Not a fit: Patients with an active second cancer, active CNS lymphoma, known cytomegalovirus infection, or who do not meet measurable disease or recovery-from-prior-therapy requirements are unlikely to be eligible or to benefit from this Phase 1 trial.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that controls disease in people with relapsed or refractory B‑cell lymphomas.

How similar studies have performed: Combining novel targeted agents with rituximab has produced benefit in some relapsed B‑cell lymphomas, but LY4584180 itself is in early-phase testing and has not yet been proven effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Scottsdale, Arizona and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, Non-Hodgkin'sLymphoma, Diffuse Large B-CellFollicular Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.