Novartis PH lb HDM201, MBG453 and venetoclax in AML or high risk MDS - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how the study drug combinations (HDM201+MBG452 and HDM201+venetoclax) effect people with AML and MDS.

What is the Condition Being Studied?

R/R Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Who Can Participate in the Study?

Adults who have:
-Relapsed/Refactory AML after having more than 1 prior therapy but less than 3 who have relapsed
-No acute promyelocytic leukemia with PML-RARA.
-No stem cell transplant within last 6 months and/or active GvHD requiring systemic immunosuppressive therapy.
-No active, known or suspected autoimmune disease

Age Group

What is Involved?

If you choose to join this study you will:
- Complete your standard of care (including blood tests, physical exams, etc.)
- Be given a small dose of the study drug (HDM201+MBG452 and HDM201+venetoclax)
- Be given increased amounts of the study drug until the known recommended dose is found
- Have a bone marrow aspirate or biopsy (small sample of tissue removed) at the time of joining

Study Details

Full Title
Novartis HDM201, MBG453: A phase lb, multi-arm, open-label, study of HDM201 in combination with MBG453 or venetoclax in adult subjects with acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00102354
NCT: NCT03940352
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center