New hope for tough lymphomas: experimental drug targets cancer protein

NCT ID NCT06090539

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study tests a new drug called BMS-986458, which works by breaking down a protein that helps lymphoma cells grow. It is being tested alone or with other lymphoma drugs in people whose non-Hodgkin lymphoma has returned or not responded to prior treatments. The trial aims to find safe doses and see if the drug can shrink tumors. About 460 adults will take part across multiple centers.

What this could mean

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

Active substance
BMS-986458 (a drug that targets and breaks down a protein in lymphoma cells), given alone or with other anti-lymphoma drugs like rituximab, glofitamab, mosunetuzumab, epcoritamab, or golcadomide
What this could lead to
If successful, this could provide a new treatment option for people with non-Hodgkin lymphoma that has not responded to or returned after prior therapies.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the drug may not work or may cause unexpected side effects. The study is testing multiple combinations, which adds complexity and uncertainty.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 460 people

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

Started

Dec 2023

Expected to finish

Oct 2028

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: * Participants ≥ 18 years of age with frontline or R/R NHL. * Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion \> 1.5 cm in the transverse diameter). * Participants must accept and follow pregnancy prevention plan. Exclusion Criteria: * Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2. * Participants with an inability to comply with listed restrictions, precautions and prohibited treatments. * Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation. * In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection. * Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. * Participants must not have known or suspected central nervous system involvement. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    72 sites in 15 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

  • Beijing Cancer hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • CHU SAINT ELOI - Departement Hematologie Clinique

    RECRUITING

    Montpellier, 34295, France

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, Paris, 94800, France

  • Helios Klinikum Berlin-Buch

    RECRUITING

    Berlin, 13125, Germany

  • Henri Mondor Hospital

    RECRUITING

    Créteil, Val-de-Marne, 94010, France

  • Hopital Claude Huriez - CHU de Lille

    RECRUITING

    Lille, Nord, 59000, France

  • Hopitaux Universitaires de Geneve (HUG)

    RECRUITING

    Geneva, 1205, Switzerland

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hôpital Saint-Louis

    RECRUITING

    Paris, 75010, France

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Local Institution - 0037

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Local Institution - 0045

    NOT_YET_RECRUITING

    Providence, Rhode Island, 02903, United States

  • Local Institution - 0047

    COMPLETED

    Lake Success, New York, 11042, United States

  • Local Institution - 0068

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • Local Institution - 0071

    NOT_YET_RECRUITING

    Southampton, Hampshire, SO16 0YD, United Kingdom

  • Local Institution - 0072

    NOT_YET_RECRUITING

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Local Institution - 0077

    NOT_YET_RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Local Institution - 0078

    NOT_YET_RECRUITING

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Local Institution - 0081

    NOT_YET_RECRUITING

    Manchester, Lancashire, M20 4BX, United Kingdom

  • Local Institution - 0084

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510555, China

  • Local Institution - 0087

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450008, China

  • Local Institution - 0090

    NOT_YET_RECRUITING

    Nagoya, Aichi-ken, 4668560, Japan

  • Local Institution - 0091

    NOT_YET_RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • Local Institution - 0092

    NOT_YET_RECRUITING

    Fukuoka, 812-8582, Japan

  • Local Institution - 0094

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

  • Local Institution - 0096

    NOT_YET_RECRUITING

    Ankara, 06170, Turkey (Türkiye)

  • Local Institution - 0097

    NOT_YET_RECRUITING

    Verona, 37134, Italy

  • Local Institution - 0098

    NOT_YET_RECRUITING

    Milan, 20132, Italy

  • Local Institution - 0099

    NOT_YET_RECRUITING

    Istanbul, 34365, Turkey (Türkiye)

  • Local Institution - 0101

    NOT_YET_RECRUITING

    Ankara, 06620, Turkey (Türkiye)

  • Local Institution - 0102

    NOT_YET_RECRUITING

    Athens, 11 527, Greece

  • Local Institution - 0103

    NOT_YET_RECRUITING

    Pátrai, Achaḯa, 26504, Greece

  • Local Institution - 0105

    NOT_YET_RECRUITING

    Santiago, Metropolitana de Santiago, 7580206, Chile

  • Local Institution - 0107

    NOT_YET_RECRUITING

    Athens, 10676, Greece

  • Local Institution - 0109

    NOT_YET_RECRUITING

    Santiago, Santiago Metropolitan, 8420383, Chile

  • Local Institution - 0110

    NOT_YET_RECRUITING

    Roma, 00168, Italy

  • Local Institution - 0111

    NOT_YET_RECRUITING

    Ravenna, 48121, Italy

  • Local Institution - 0112

    NOT_YET_RECRUITING

    Pisa, 56126, Italy

  • Local Institution - 0113

    NOT_YET_RECRUITING

    Milan, 20133, Italy

  • Local Institution - 0115

    NOT_YET_RECRUITING

    Roma, 00144, Italy

  • Local Institution - 0116

    NOT_YET_RECRUITING

    Brescia, 25123, Italy

  • Local Institution - 0118

    NOT_YET_RECRUITING

    Antofagasta, AN, 1240000, Chile

  • Local Institution - 0119

    NOT_YET_RECRUITING

    Hong Kong, 0, Hong Kong

  • Local Institution - 0121

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1981 HV, Netherlands

  • Local Institution - 0122

    NOT_YET_RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

  • Local Institution - 0123

    NOT_YET_RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

  • Local Institution - 0124

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68105, United States

  • Local Institution - 0125

    NOT_YET_RECRUITING

    Lyon, Nan, 69373, France

  • Local Institution - 0128

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Local Institution - 0130

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Local Institution - 0131

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200092, China

  • Maastricht UMC+

    RECRUITING

    Maastricht, Limburg, 6229 HX, Netherlands

  • Mayo Clinic in Arizona - Phoenix

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Rochester, Minnesota

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Ospedale Regionale Bellinzona e Valli

    RECRUITING

    Bellinzona, Canton Ticino, 6500, Switzerland

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45122, Germany

  • Universitaetsklinikum des Saarlandes

    RECRUITING

    Homburg, Saarland, 66424, Germany

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University Medical Center Groningen

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • University of Yamanashi Hospital

    RECRUITING

    Chūō, Yamanashi, 4093898, Japan

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

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