New immunotherapy combo shows promise for Tough-to-Treat MDS

NCT ID NCT04812548

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

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 2 trial tested a new drug called sabatolimab, combined with two standard chemotherapy drugs (azacitidine and venetoclax), in 20 adults with high or very high risk myelodysplastic syndromes (MDS) who could not have intensive chemotherapy or a stem cell transplant. The goal was to see if the combination was safe and could lead to complete remission. The study was terminated early, so results are limited.

What this could mean

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

Active substance: sabatolimab (an experimental immunotherapy) combined with azacitidine and venetoclax (standard chemotherapy drugs)
What this could lead to: If it works, this combination could offer a new treatment option for people with high-risk MDS who cannot have intensive chemotherapy or a stem cell transplant.
What could go wrong: This was a small, early-phase trial (20 participants) that was terminated, so results are limited. The combination may cause serious side effects, and it is unclear if it works better than existing treatments.

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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 SYNDROME (MDS)

Contacts and locations

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Locations

Novartis Investigative Site

Brasschaat, 2930, Belgium
Novartis Investigative Site

Marseille, 13273, France
Novartis Investigative Site

Nice, 06202, France
Novartis Investigative Site

Düsseldorf, 40479, Germany
Novartis Investigative Site

Stuttgart, 70376, Germany
Novartis Investigative Site

Alexandroupoli, Evros, 681 00, Greece
Novartis Investigative Site

Pátrai, 265 00, Greece
Novartis Investigative Site

Nyíregyháza, 4400, Hungary
Novartis Investigative Site

Genova, GE, 16132, Italy
Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

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