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New drug takes aim at Hard-to-Treat blood cancers

NCT ID NCT07101328

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This early-stage trial tests a new drug called LY4152199 in about 215 adults with certain types of blood cancer (like follicular lymphoma or diffuse large B-cell lymphoma) that have already been treated. The drug is designed to help the body's immune cells attack the cancer. The main goals are to find a safe dose and to see if the drug can shrink tumors. Participants may continue treatment as long as they benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4152199 (a drug that helps immune cells attack cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for people with certain types of blood cancer that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial, so the main goal is safety, not proof of effectiveness. The drug may not work or could cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 215 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator. * Participants with select tumor types must have measurable or assessable disease as defined below: * Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement. * Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing. * Must be able to comply with inpatient/outpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation. * Must have adequate organ function. Phase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed/refractory B-cell malignancy. Phase 1 Dose Optimization (Cohort B) Participants \- Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL). Exclusion Criteria: All Participants * Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL). * Known or suspected central nervous system (CNS) involvement by systemic lymphoma. * Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia. * Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals. * Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria. * Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH). * Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval. * History of autoimmune disease * Significant cardiovascular disease * Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process * Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF). * Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins). * Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody). * Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention. * Known hypersensitivity to any component or excipient of LY4152199.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm Burkitt lymphoma diffuse large B-cell lymphoma follicular lymphoma Lymphoma, B-Cell, Marginal Zone lymphoma, non-Hodgkin, familial mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell lymphoma Burkitt lymphoma Leukemia, B-cell Leukemia, lymphocytic, chronic, B-cell Lymphoma, B-cell marginal zone Lymphoma, follicular Lymphoma, large B-cell, diffuse Lymphoma, mantle cell Lymphoma, non-Hodgkin Waldenstrom macroglobulinemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIDPORT Sp. z o.o.

    NOT_YET_RECRUITING

    Skorzewo, 60-185, Poland

  • AP-HP Hopital Saint-Louis

    NOT_YET_RECRUITING

    Paris, 75010, France

  • Aarhus University Hospital

    NOT_YET_RECRUITING

    Aarhus, N 8200, Denmark

  • Asan Medical Center

    NOT_YET_RECRUITING

    Seoul, 05505, South Korea

  • BC Cancer - Vancouver

    NOT_YET_RECRUITING

    Vancouver, V5Z 1L3, Canada

  • CHU de Lille - Hopital Claude Huriez

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Center for Cancer and Organ Diseases - Rigshospitalet

    NOT_YET_RECRUITING

    Copenhagen, 2100, Denmark

  • Charite Universitaetsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, 10117, Germany

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Dana-Farber Cancer Institute

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Froedtert Hospital and the Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Hospital Universitario Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Institut Catala d'Oncologia - L'Hospitalet

    NOT_YET_RECRUITING

    Barcelona, 08908, Spain

  • Intermountain Healthcare

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84111, United States

  • Istituto Clinico Humanitas

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • LMU Klinikum Muenchen-Campus Grosshadern

    NOT_YET_RECRUITING

    München, 80336, Germany

  • Lady Davis Institute for Medical Research Jewish General Hospital

    NOT_YET_RECRUITING

    Montreal, H3T 1E2, Canada

  • Leeds Teaching Hospitals NHS Trust

    NOT_YET_RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Linear Clinical Research

    NOT_YET_RECRUITING

    Nedlands, 6009, Australia

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • National Cancer Center Hospital

    NOT_YET_RECRUITING

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    NOT_YET_RECRUITING

    Chiba, 277-8577, Japan

  • New York University (NYU) Clinical Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Okayama University Hospital

    RECRUITING

    Okayama, 700-8558,, Japan

  • Oxford University Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Pratia MCM Krakow

    NOT_YET_RECRUITING

    Krakow, 30-727, Poland

  • Rutgers Cancer Institute of New Jersey

    NOT_YET_RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • Swedish Cancer Institute (SCI)

    RECRUITING

    Seattle, Washington, 98104, United States

  • The Alfred Hospital

    NOT_YET_RECRUITING

    Melbourne, VIC, 3004, Australia

  • The Cancer Institute Hospital of JFCR

    RECRUITING

    Tokyo, 135-8550, Japan

  • The University of Chicago Medical Center (UCMC)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Universitaetsklinikum Muenster

    NOT_YET_RECRUITING

    Münster, 48149, Germany

  • University Health Network (UHN) - Princess Margaret Cancer Centre

    NOT_YET_RECRUITING

    Toronto, M5G 1Z5, Canada

  • University of Colorado Denver - School of Medicine - Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045-2559, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan Comprehensive Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania Abramson Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern

    RECRUITING

    Dallas, Texas, 75244, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

  • Yale University School of Medicine - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520-8028, United States

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Other studies related to the condition(s) this trial covers.