Clinical trial Recruiting at 21 sites Phase 1 Interventional Ages 18 and up

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

Official 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

Run by Eli Lilly and Company · NCT07226843 · Data updated 2026-11-12

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
Ages18 Years and up
SexAll
Enrollment460 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations46 sites (Scottsdale, Arizona and 45 other locations)
StatusRecruiting
StartedApril 17, 2026
Main results expectedSeptember 2028
Study endsFebruary 2030
Registry record updatedNovember 4, 2026
Trial IDNCT07226843 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Mayo Clinic - Scottsdale
    Scottsdale, Arizona, United States
    Recruiting
  • City of Hope
    Duarte, California, United States
    Recruiting
  • University of California, Los Angeles (UCLA) - Medical Center
    Los Angeles, California, United States
    Recruiting
  • University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, United States
    Recruiting
  • Colorado Blood Cancer Institute
    Denver, Colorado, United States
    Recruiting
  • University of Miami - Sylvester Cancer Center
    Miami, Florida, United States
    Recruiting
Show 40 more locations
  • Florida Cancer Specialists - Sarasota
    Sarasota, Florida, United States
    Recruiting
  • Emory University Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Mayo Clinic - Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Columbia University
    New York, New York, United States
    Recruiting
  • University of Rochester
    Rochester, New York, United States
    Recruiting
  • The Ohio State University (OSU)
    Columbus, Ohio, United States
    Recruiting
  • Sarah Cannon Research Institute
    Nashville, Tennessee, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • Texas Oncology - DFW (Sammons CC)
    Dallas, Texas, United States
    Recruiting
  • University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)
    Seattle, Washington, United States
    Recruiting
  • Froedtert Hospital and the Medical College of Wisconsin
    Milwaukee, Wisconsin, United States
    Recruiting
  • Okayama University Hospital
    Okayama, Japan
    Recruiting
  • Cancer Institute Hospital of JFCR
    Tokyo, Japan
    Recruiting
  • Oregon Health & Science University (OHSU)
    Portland, Oregon, United States
    Not yet recruiting
  • Baylor College of Medicine
    Houston, Texas, United States
    Not yet recruiting
  • CHU de Nantes - Hotel-Dieu
    Nantes, France
    Not yet recruiting
  • Institut Curie
    Paris, France
    Not yet recruiting
  • CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
    Pessac, France
    Not yet recruiting
  • HCL Centre Hospitalier Lyon Sud
    Pierre-Bénite, France
    Not yet recruiting
  • Oncopole Claudius Regaud
    Toulouse, France
    Not yet recruiting
  • Charite Universitaetsmedizin Berlin
    Berlin, Germany
    Not yet recruiting
  • Universitaetsklinikum Koeln (AoeR)
    Cologne, Germany
    Not yet recruiting
  • Universitaetsklinikum Essen
    Essen, Germany
    Not yet recruiting
  • Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
    Frankfurt am Main, Germany
    Not yet recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
    Bologna, Italy
    Not yet recruiting
  • Istituto Europeo di Oncologia
    Milan, Italy
    Not yet recruiting
  • National Cancer Center Hospital East
    Chiba, Japan
    Not yet recruiting
  • Pratia Onkologia Katowice
    Katowice, Poland
    Not yet recruiting
  • Pratia MCM Krakow
    Krakow, Poland
    Not yet recruiting
  • AIDPORT Sp. z o.o.
    Skorzewo, Poland
    Not yet recruiting
  • Instytut Hematologii i Transfuzjologii w Warszawie
    Warsaw, Poland
    Not yet recruiting
  • Institut Catala d'Oncologia - L'Hospitalet
    Barcelona, Spain
    Not yet recruiting
  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
    Madrid, Spain
    Not yet recruiting
  • King's College Hospital
    London, United Kingdom
    Not yet recruiting
  • The Royal Marsden NHS Foundation Trust
    London, United Kingdom
    Not yet recruiting
  • Nottingham City Hospital
    Nottingham, United Kingdom
    Not yet recruiting
  • Derriford Hospital
    Plymouth, United Kingdom
    Not yet recruiting
  • University Hospital Southampton NHS Foundation Trust
    Southampton, United Kingdom
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 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.