The primary objectives of this study are to evaluate the safety, tolerability and to
determine the recommended Phase 2 dose (RP2D) of magrolimab (Mag) in combination with the
anti-leukemia therapies of venetoclax (Ven) and azacitidine (Aza) (Cohort 1), mitoxantrone,
etoposide, and cytarabine (MEC) (Cohort 2) and CC-486 (Cohort 3) respectively in participants
with acute myeloid leukemia (AML), to evaluate the efficacy of magrolimab in combination with
the anti-leukemia therapies as determined by the rate of complete remission (CR) (Phase 2
Cohorts 1 and 2), and/or complete remission with incomplete hematologic recovery (CRi)
(CR/CRi) (Phase 2 Cohort 2) and to evaluate the efficacy of magrolimab in combination with
anti-leukemia therapy CC-486 as determined by the minimal residual disease (MRD) negative CR
rate (Phase 2 Cohort 3).
This study consists of 3 safety run-in cohorts;
Safety Run-in Cohort 1 (1L Unfit AML Mag + Ven + Aza)
Participants will receive treatment at the assigned dose level for at least 4 cycles in the
Safety Run-in cohorts, after which they may continue at the assigned dose level or switch to
the RP2D upon agreement between the investigator and the sponsor. After completion of each
safety run-in cohort and identification of the RP2D for that cohort, participants will be
enrolled into the corresponding Phase 2 cohorts;
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.