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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 460 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 46 sites (Scottsdale, Arizona and 45 other locations) |
| Status | Recruiting |
| Started | April 17, 2026 |
| Main results expected | September 2028 |
| Study ends | February 2030 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07226843 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
- Study coordinator: Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Non-Hodgkin Lymphoma Sample Collection for MRD Testing
This study tests a blood-based and tissue-based approach to see if a molecular residual disease test can detect lingering cancer in adults with aggressive NHL who are starting standard therapy.
-
MK-1045 and Rituximab in Follicular Lymphoma
This study tests whether adding MK-1045 to rituximab can help people with follicular lymphoma after standard therapy.
-
Mosunetuzumab and Zeprumetostat in Follicular Lymphoma
This study tests whether a combination of Mosunetuzumab and Zeprumetostat can help adults with follicular lymphoma.
-
Zanubrutinib plus obinutuzumab and lenalidomide for first-line follicular lymphoma
This trial tests whether the combination of zanubrutinib, obinutuzumab, and lenalidomide is safe and effective as a chemotherapy-free first treatment for adults with untreated follicular lymphoma.
-
Off-the-shelf CAR-T Allo-QuadCAR01-T targeting CD19 and CD20 for relapsed or refractory B‑cell cancers
This study will test an off-the-shelf donor CAR-T that targets CD19 and CD20 to try to treat adults with relapsed or refractory B‑cell lymphomas or leukemias.
-
Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL
This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.