Sabatolimab + HMAs for Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Main objective of this study is to describe and evaluate safety and efficacy of MBG453 (sabatolimab) in combination with FDA approved HMAs of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI))

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults diagnosed with higher-risk Myelodysplastic Syndrome (MDS) who haven't had certain treatments like chemotherapy for MDS. They should be in a condition where stem cell transplant isn't an option, have decent organ function, and can follow study procedures. Those with other cancers or who've had organ transplants aren't eligible.

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study

AST and ALT ≤ 3 × upper limit of normal (ULN)

I can communicate well and follow the study's requirements.

See 9 more

Exclusion Criteria

I have MDS, was treated with lenalidomide, but it didn't work.

I have been treated for a serious blood disorder with specific drugs, but not more than once with certain ones.

I have lower risk MDS and was treated with supportive care or not treated at all.

See 7 more

Treatment Details

Interventions

Azacitidine (DNA Methyltransferase Inhibitor)
Decitabine (DNA Methyltransferase Inhibitor)
INQOVI (oral decitabine) (DNA Methyltransferase Inhibitor)
MBG453 (Monoclonal Antibodies)

Trial OverviewThe trial is testing the safety and effectiveness of Sabatolimab combined with Hypomethylating Agents (HMAs), which are FDA-approved drugs for MDS treatment. These include intravenous Decitabine, Azacitidine, or oral Decitabine (INQOVI).

Participant Groups

1Treatment groups

Experimental Treatment

Group I: MBG453 (sabatolimab) + HMAExperimental Treatment4 Interventions

MBG453 + HMA (azacitidine, decitabine, or INQOVI (oral decitabine))

Azacitidine is already approved in Canada, Japan for the following indications: