Novartis: Ph2 of MBG453 (Myelodysplastic Syndrome) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the most effective, safe dose of an experimental drug called sabatolimab (study drug) in combination with other drugs already commonly used to treat MDS.

What is the Condition Being Studied?

Intermediate, high, or very high risk myelodysplastic syndrome (MDS)

Who Can Participate in the Study?

Adults who:
- Have confirmed MDS; OR
- Are not suitable for myeloablative/chemotherapy or stem cell transplant; OR
- Have not had prior exposure to TIM-3 directed therapy
- Have not had previous treatment for intermediate, high, or very high risk MDS

For more information about who can join this study, please contact the study team at christine.daly@duke.edu or 919-660-2077.

What is Involved?

This study is divided into 3 different phases (screening, core phase, and extension phase).

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period you will:
- Have a physical exam
- Have blood draws
- Have a heart scan (ECG)
- Be tested for HIV, Hepatitis B and C

After the screening period and during the core phase you will:
- Have a physical exam
- Have blood collected
- Vital signs taken
- Have a heart scan (ECG)
- Complete quality of life questionnaires
- Receive the study drug as an infusion (IV) on day 8 of every drug cycle (alone or with decitabine or INQOVI or azacytidine)

During the extension phase you will:
- Have blood draws
- Complete quality of life questionnaires

Once you stop taking the study drug, you will enter a follow-up period. The study team will call you or see you in the clinic 30, 90, and 150 days after you stop taking the study drug to see how you are feeling.

Study Details

Full Title
Single-arm, open label, phase II study of MBG453 (sabatolimab) added to FDA approved Hypomethylating agents of investigator?s choice (IV/SC/Oral) for patients with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria (US multi-center) (STIMULUS MDS-US)
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00109030
NCT: NCT04878432
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698