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Sabatolimab safety tracked in extended cancer study

NCT ID NCT05201066

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This study looks at the long-term safety of the drug sabatolimab in people with myelodysplastic syndromes or chronic myelomonocytic leukemia who already benefited from it in a previous trial. About 33 participants will continue treatment and be monitored for side effects. The goal is to gather more safety information, not to test if the drug works.

What this could mean

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

Active substance
sabatolimab (a cancer immunotherapy drug, given as an infusion)
What this could lead to
If successful, this study could show that long-term sabatolimab is safe for people with certain blood cancers, supporting its continued use.
What could go wrong
This is a small, early-phase safety study with only 33 participants, so results may not apply to everyone. It does not test whether the drug works better than other options.

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

33 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Feb 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

12 to 99 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: 1. Participant is currently enrolled in a Novartis-sponsored study with sabatolimab, is being treated with sabatolimab, and has fulfilled all requirements in the parent study. 2. Participant is currently benefiting from the treatment with sabatolimab as determined by guidelines of the parent protocol and investigator's judgment. 3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. 4. Willingness and ability to comply with scheduled visits, treatment plan and any other study procedures. 5. Written informed consent obtained prior to enrolling in the roll-over study. Exclusion Criteria: 1. Participants in cohorts or treatment groups not receiving sabatolimab in the parent protocol. 2. Participant has been permanently discontinued from sabatolimab treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason. 3. Participant currently has unresolved toxicities for which sabatolimab dosing has been interrupted in the parent study (participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow sabatolimab dosing to resume). 4. Pregnant or nursing (lactating) women. Where pregnancy is defined as the state of a female after conception confirmed by a positive serum hCG laboratory test and until the termination of gestation. 5. Participant not willing to comply with the contraception requirements outlined in the exclusion criteria of the parent protocol. 6. Local access to commercially available sabatolimab for parent protocol indications. Other protocol-defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

chronic myelomonocytic leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Leukemia, myelomonocytic, chronic Myelodysplastic syndromes

Contacts and locations

Locations

  • Huntsman Cancer Institute Univ of Utah

    Salt Lake City, Utah, 84112 0550, United States

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Tianjin, 300020, China

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Novartis Investigative Site

    Alexandroupoli, 681 00, Greece

  • Novartis Investigative Site

    Pátrai, 265 04, Greece

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

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