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New antibody cocktail aimed at MDS shows early promise, but study halted

NCT ID NCT04810611

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested combinations of three antibody drugs (sabatolimab, NIS793, and canakinumab) in 33 adults with lower-risk myelodysplastic syndrome (MDS), a blood disorder. The main goal was to check safety and find the right doses. The study was terminated early, so its findings are limited, but it aimed to reduce the need for blood transfusions in patients.

What this could mean

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

Active substance
sabatolimab, NIS793, and canakinumab (antibody drugs targeting immune signals)
What this could lead to
If successful, this could point toward new drug combinations to manage lower-risk MDS and reduce the need for blood transfusions.
What could go wrong
This was a very early (phase 1) study with only 33 participants, and it was terminated early, so results are limited. The drugs may not prove effective or safe in larger trials.

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

33 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 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 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.

Key Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF). 3. Patients must have a diagnosis prior to participation in the study of IPSS-R very low, low, or intermediate risk MDS with ≤10% bone marrow blasts and one or more of the following: 1. Symptomatic anemia with hemoglobin \<10 g/dL that has relapsed after or is refractory to ESAs (or the patient is intolerant to ESAs) 2. Symptomatic anemia with hemoglobin \<10 g/dL) that is ESA-naive with EPO level ≥ 500 /uL 3. Thrombocytopenia with platelets \<30,000/uL or with clinically significant bleeding or bruising and platelets \<50,000/uL 4. Neutropenia with an absolute neutrophil count (ANC) \<500/ µL or with recurrent and/or severe infections and an ANC that is \<1000/ µL and amenable to response assessments by International Working Group (IWG) response criteria in myelodysplasia (Cheson et al 2006) 4. Patients who are refractory to, intolerant of, or ineligible/unable to receive SOC therapeutic options including lenalidomide 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2 6. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions' guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study - Key Exclusion Criteria: 1. Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment. 2. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. 3. Patients with chronic myelomonocytic leukemia (CMML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN) 4. Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or ESAs anytime ≤ 2 weeks (or 5 half-lives, whichever is longer) prior to start of study treatment. 5. Systemic chronic corticosteroid therapy (\>10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed. 6. For arms containing canakinumab: Patients with ANC \< 500 /µL

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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 Oncology

    Duarte, California, 91010, United States

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • MD Anderson Cancer Center/University of Texas MD Anderson

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital .

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Prahran, Victoria, 3181, Australia

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • The Ohio State University Wexner Medical Center .

    Columbus, Ohio, 43210, United States

More trials for these conditions

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