Lymphoma, Non-Hodgkin'sPhase 1NCT07226843
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
A Phase 1 study testing LY4584180 and Rituximab in people with Lymphoma, Non-Hodgkin's and Lymphoma, Diffuse Large B-Cell, run by Eli Lilly and Company at 46 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell, Follicular Lymphoma
- What is being tested?
- LY4584180 and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 46 sitesin 8 countries
- Study dates
- 17 Apr 2026to Feb 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Other non-Hodgkin lymphoma
- Has measurable disease
- Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
Who cannot join
- 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
Trial locations and contacts
46 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
46 sites in 8 countries
United States21 sites, 21 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
The Ohio State University (OSU)
Columbus, Ohio, 43210
- Recruiting
Texas Oncology - DFW (Sammons CC)
Dallas, Texas, 75246
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
City of Hope
Duarte, California, 91010
- Not yet recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, 90059
- Recruiting
University of Miami - Sylvester Cancer Center
Miami, Florida, 33136
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
- Recruiting
Columbia University
New York, New York, 10032
- Not yet recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
- Recruiting
University of Rochester
Rochester, New York, 14618
- Recruiting
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
- Recruiting
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34236
- Recruiting
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
- Recruiting
University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)
Seattle, Washington, 98195
France5 sites, 5 recruiting
- Not yet recruiting
CHU de Nantes - Hotel-Dieu
Nantes, 44093
- Not yet recruiting
Institut Curie
Paris, 75005
- Not yet recruiting
CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
Pessac, 33604
- Not yet recruiting
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
- Not yet recruiting
Oncopole Claudius Regaud
Toulouse, 31059
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
King's College Hospital
London, SE5 9RS
- Not yet recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
- Not yet recruiting
Nottingham City Hospital
Nottingham, NG5 1PB
- Not yet recruiting
Derriford Hospital
Plymouth, PL6 8DH
- Not yet recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Germany4 sites, 4 recruiting
- Not yet recruiting
Charite Universitaetsmedizin Berlin
Berlin, 10117
- Not yet recruiting
Universitaetsklinikum Koeln (AoeR)
Cologne, 50937
- Not yet recruiting
Universitaetsklinikum Essen
Essen, 45147
- Not yet recruiting
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, 60590
Poland4 sites, 4 recruiting
- Not yet recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Not yet recruiting
Pratia MCM Krakow
Krakow, 30-727
- Not yet recruiting
AIDPORT Sp. z o.o.
Skorzewo, 60-185
- Not yet recruiting
Instytut Hematologii i Transfuzjologii w Warszawie
Warsaw, 02-776
Japan3 sites, 3 recruiting
- Not yet recruiting
National Cancer Center Hospital East
Chiba, 277-8577
- Not yet recruiting
Okayama University Hospital
Okayama, 700-8558,
- Not yet recruiting
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, 40138
- Not yet recruiting
Istituto Europeo di Oncologia
Milan, 20141
Spain2 sites, 2 recruiting
- Not yet recruiting
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
- Not yet recruiting
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040
About this study
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
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.
- Being tested
- LY4584180, Rituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4584180Drug
administered orally
RituximabDrug
administered through IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a-Monotherapy Dose Escalation (Cohort A1) | Experimental | LY4584180 monotherapy administered orally Receives: Drug: LY4584180 |
| Phase 1a-Monotherapy Dose Optimization (Cohort A2) | Experimental | LY4584180 monotherapy administered orally Receives: Drug: LY4584180 |
| Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3) | Experimental | LY4584180 monotherapy administered orally Receives: Drug: LY4584180 |
| Phase 1b-Dose Expansion-Combination (Cohort B4) | Experimental | LY4584180 administered orally in combination with rituximab administered through IV infusion Receives: Drug: LY4584180; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Measured: Baseline up to Day 28
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline up to 3 Years
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
Measured: Baseline up to 3 Years
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180
PK: Cmax of LY4584180
Measured: Baseline to Day 8
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180
PK: AUC versus time curve of LY4584180
Measured: Baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start17 Apr 2026
- Primary completionSep 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-Hodgkin'sStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226843
- Sponsor's protocol ID
- 27804
- Other IDs
- J6Y-OX-JBFA, 2025-523601-16-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07226843
- Acronym / sponsor ID
- 27804
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a-Monotherapy Dose Escalation (Cohort A1) | Experimental | Drug: LY4584180LY4584180 monotherapy administered orally |
| Phase 1a-Monotherapy Dose Optimization (Cohort A2) | Experimental | Drug: LY4584180LY4584180 monotherapy administered orally |
| Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3) | Experimental | Drug: LY4584180LY4584180 monotherapy administered orally |
| Phase 1b-Dose Expansion-Combination (Cohort B4) | Experimental | Drug: LY4584180, Drug: RituximabLY4584180 administered orally in combination with rituximab administered through IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Has measurable disease
- Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4584180administered orally | Drug | Phase 1a-Monotherapy Dose Escalation (Cohort A1), Phase 1a-Monotherapy Dose Optimization (Cohort A2), Phase 1b-Dose Expansion-Combination (Cohort B4), Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3) |
| Rituximabadministered through IV infusion | Drug | Phase 1b-Dose Expansion-Combination (Cohort B4) |
Primary outcome
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
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
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)
2 secondary outcomes
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180
Time frame: Baseline to Day 8
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180
Time frame: Baseline to Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4584180 and Rituximab in people with Lymphoma, Non-Hodgkin's and Lymphoma, Diffuse Large B-Cell, run by Eli Lilly and Company at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, France, United Kingdom, Germany, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities (time frame: Baseline up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.