ClinicalTrials.gg
RecruitingNCT07226843Updated Nov 4, 2026

A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers

A Phase 1 interventional study of LY4584180 and Rituximab in Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell and Follicular Lymphoma, sponsored by Eli Lilly and Company. Recruiting at 46 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Primary conditionLymphoma, FollicularRegistry: Lymphoma, Non-HodgkinReclassifiedWhy we changed it
Registry
Lymphoma, Non-Hodgkin — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, Follicular
Why
  1. The study's listed conditions name Lymphoma, Follicular, a narrower term within Lymphoma, Non-Hodgkin.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 4, 2026Site recruiting status changedPrimary completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
460
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphoma, Non-Hodgkin's
  • Lymphoma, Diffuse Large B-Cell
  • Follicular Lymphoma

Browse trials for

03

In context

Lymphoma, Follicular Reclassified

1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.

This study's planned enrollment of 460 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.

Browse Lymphoma, Follicular studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Compared within Lymphoma, Follicular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphoma, Non-Hodgkin. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Has been treated for the following blood cancers and has received at least 2 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
  • Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy

Exclusion criteria

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 or C infection or uncontrolled
  • Has known significant heart disease
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
460 participants (estimated)

Study arms

  • Experimental
    Phase 1a-Monotherapy Dose Escalation (Cohort A1)

    LY4584180 monotherapy administered orally

    Drug: LY4584180

  • Experimental
    Phase 1a-Monotherapy Dose Optimization (Cohort A2)

    LY4584180 monotherapy administered orally

    Drug: LY4584180

  • Experimental
    Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)

    LY4584180 monotherapy administered orally

    Drug: LY4584180

  • Experimental
    Phase 1b-Dose Expansion-Combination (Cohort B4)

    LY4584180 administered orally in combination with rituximab administered through IV infusion

    Drug: LY4584180 · Drug: Rituximab

Interventions

  • DrugLY4584180

    administered orally

  • administered through IV infusion

06

What researchers measure

Primary outcomes

  1. Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

    Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

    Time frame: Baseline up to Day 28

  2. 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

    Time frame: Baseline up to 3 Years

  3. To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)

    To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)

    Time frame: Baseline up to 3 Years

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180

    PK: Cmax of LY4584180

    Time frame: Baseline to Day 8

  2. PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180

    PK: AUC versus time curve of LY4584180

    Time frame: Baseline to Day 8

07

Study locations

21 of 46 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Sep 2028, 29 months after the start.

Of 84 industry-sponsored phase 1 interventional studies under Lymphoma, Follicular, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 71. This study's planned 29 months is below that.

Counting every sponsor, half of 173 studies reached it within 51 months; a quarter within 30 and three quarters within 80.

Primary completion moved once since we started tracking on Sep 25, 2026: Apr 2027 → Sep 2028, on Oct 6, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2025
First posted
Nov 12, 2025
StartActual
Apr 17, 2026
Primary completionEst.
Sep 2028was Apr 2027
CompletionEst.
Feb 2030
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Okayama University Hospital · Okayama, JapanNot yet recruiting→Recruiting
  • Cancer Institute Hospital of JFCR · Tokyo, JapanNot yet recruiting→Recruiting
Nov 4, 2026
Primary completion
Apr 2027→Sep 2028
Oct 6, 2026
Show all 2 updates
  1. Nov 4, 2026
    2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Okayama University Hospital · Okayama, JapanNot yet recruiting→Recruiting
    • Cancer Institute Hospital of JFCR · Tokyo, JapanNot yet recruiting→Recruiting
    + 1 other change: verification date
  2. Oct 6, 2026
    Primary completion Apr 2027→Sep 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07226843
Responsible party
Sponsor
First posted
Nov 12, 2025
Start date
Apr 17, 2026
Primary completion
Sep 2028 (estimated)
Completion
Feb 2030 (estimated)
Last update
Nov 4, 2026

Study contacts

Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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