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New hope for MDS patients? study tests MBG453 combo but ends early

NCT ID NCT03946670

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested adding an experimental drug called MBG453 to standard chemotherapy for people with a serious bone marrow disorder called myelodysplastic syndrome (MDS). The trial included 127 adults with high-risk MDS who could not have a stem cell transplant. The goal was to see if the combination could improve remission rates and delay disease progression, but the study was stopped early.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

127 people

The number who actually took part.

Started

Jun 2019

Finished

Jul 2024

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 to 100 years

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: * Signed informed consent must be obtained prior to participation in the study. * Age ≥ 18 years at the date of signing the informed consent form (ICF)-. Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R): * Very high * High * Intermediate with at least ≥ 5% bone marrow blast * Not eligible at the time of screening, for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions * Not eligible at the time of screening, for hematopoietic stem-cell transplantation (HSCT) according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Exclusion Criteria: * Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines are allowed except if the drug was administered within 4 months prior to randomization. * Previous first-line treatment for higher risk MDS with chemotherapy or any other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine. * History of severe hypersensitivity reactions to any ingredient of the study treatment (azacitidine, decitabine or MGB453) or their excipients, or to monoclonal antibodies (mAbs). * Currently using or used within 14 days prior to randomization of systemic, steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment. * Investigational treatment for MDS received within 4 weeks prior to randomization. In case of a checkpoint inhibitor: 4 months minimum prior to randomization interval is necessary to allow enrollment. * Active autoimmune disease requiring systemic therapy (e.g.corticosteroids). * Live vaccine administered within 30 Days prior to randomization.

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Myelodysplastic syndromes

Contacts and locations

Locations

  • City Of Hope National Med Center

    Duarte, California, 91010, United States

  • City of Hope National Medical Center Medical Oncology & Therapeutic

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75251, United States

  • Novartis Investigative Site

    Vienna, 1140, Austria

  • Novartis Investigative Site

    Brasschaat, 2930, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4, Canada

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Alexandroupoli, 681 00, Greece

  • Novartis Investigative Site

    Larissa, 411 10, Greece

  • Novartis Investigative Site

    Pátrai, 265 04, Greece

  • Novartis Investigative Site

    Hong Kong, Hong Kong

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Nyíregyháza, 4400, Hungary

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582, Japan

  • Novartis Investigative Site

    Fukushima, Fukushima, 960 1295, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193, Japan

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-0008, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 983 8520, Japan

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8501, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8677, Japan

  • Novartis Investigative Site

    Gifu, 500 8513, Japan

  • Novartis Investigative Site

    Osaka, 545-8586, Japan

  • Novartis Investigative Site

    Seoul, Korea, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Köseköy, Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Ohio State Comprehensive Cancer Center James Cancer Hospital

    Columbus, Ohio, 73210, United States

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520, United States

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