RecruitingRecruiting
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
NCT07226843 · Eli Lilly and Company
In plain English
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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
About this study
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.
Eligibility 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
Study design
Enrollment target: 460 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-17
Estimated completion: 2030-02
Last updated: 2026-06-04
Interventions
Drug: LY4584180Drug: Rituximab
Primary outcomes
- • Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities (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 (Baseline up to 3 Years)
- • To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR) (Baseline up to 3 Years)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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
All locations (46)
Mayo Clinic - ScottsdaleNot Yet Recruiting
Scottsdale, Arizona, United States
City of HopeRecruiting
Duarte, California, United States
University of California, Los Angeles (UCLA) - Medical CenterNot Yet Recruiting
Los Angeles, California, United States
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterNot Yet Recruiting
San Francisco, California, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
University of Miami - Sylvester Cancer CenterNot Yet Recruiting
Miami, Florida, United States
Florida Cancer Specialists - SarasotaRecruiting
Sarasota, Florida, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo Clinic - RochesterNot Yet Recruiting
Rochester, Minnesota, United States
Columbia UniversityRecruiting
New York, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
The Ohio State University (OSU)Recruiting
Columbus, Ohio, United States
Oregon Health & Science University (OHSU)Not Yet Recruiting
Portland, Oregon, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Texas Oncology - DFW (Sammons CC)Not Yet Recruiting
Dallas, Texas, United States
Baylor College of MedicineNot Yet Recruiting
Houston, Texas, United States
University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)Recruiting
Seattle, Washington, United States
Froedtert Hospital and the Medical College of WisconsinNot Yet Recruiting
Milwaukee, Wisconsin, United States
CHU de Nantes - Hotel-DieuNot Yet Recruiting
Nantes, France
Institut CurieNot Yet Recruiting
Paris, France
CHU Bordeaux - Hopital Haut-Leveque - Centre Francois MagendieNot Yet Recruiting
Pessac, France
HCL Centre Hospitalier Lyon SudNot Yet Recruiting
Pierre-Bénite, France
Oncopole Claudius RegaudNot Yet Recruiting
Toulouse, France
Charite Universitaetsmedizin BerlinNot Yet Recruiting
Berlin, Germany
Universitaetsklinikum Koeln (AoeR)Not Yet Recruiting
Cologne, Germany
Universitaetsklinikum EssenNot Yet Recruiting
Essen, Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe UniversitaetNot Yet Recruiting
Frankfurt am Main, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant OrsolaNot Yet Recruiting
Bologna, Italy
Istituto Europeo di OncologiaNot Yet Recruiting
Milan, Italy
National Cancer Center Hospital EastNot Yet Recruiting
Chiba, Japan
Okayama University HospitalNot Yet Recruiting
Okayama, Japan
Cancer Institute Hospital of JFCRNot Yet Recruiting
Tokyo, Japan
Pratia Onkologia KatowiceNot Yet Recruiting
Katowice, Poland
Pratia MCM KrakowNot Yet Recruiting
Krakow, Poland
AIDPORT Sp. z o.o.Not Yet Recruiting
Skorzewo, Poland
Instytut Hematologii i Transfuzjologii w WarszawieNot Yet Recruiting
Warsaw, Poland
Institut Catala d'Oncologia - L'HospitaletNot Yet Recruiting
Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez DiazNot Yet Recruiting
Madrid, Spain
King's College HospitalNot Yet Recruiting
London, United Kingdom
The Royal Marsden NHS Foundation TrustNot Yet Recruiting
London, United Kingdom
Nottingham City HospitalNot Yet Recruiting
Nottingham, United Kingdom
Derriford HospitalNot Yet Recruiting
Plymouth, United Kingdom
University Hospital Southampton NHS Foundation TrustNot Yet Recruiting
Southampton, United Kingdom