Trial Identifiers
Use the hyperlinks, where available to access additional clinical trial information.
Scientific Title
A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Myeloid Malignancies
Commercial Sponsor
Gilead Sciences, Inc.
Summary
Safety Run-in Cohort 1 (1L Unfit AML Mag+Ven+Aza)
: Participants with newly diagnosed untreated AML who are ineligible for intensive induction chemotherapy will receive magrolimab, venetoclax and azacitidine.
THIS COHORT IS CLOSED FOR ENROLLMENT UNTIL FURTHER NOTICE.
Biological: Magrolimab
: Administered intravenously
This study consists of 3 safety run-in cohorts;Safety Run-in Cohort 1 (1L Unfit AML Mag + Ven + Aza)Safety Run-in Cohort 2 (R/R AML Mag + MEC)Safety Run-in Cohort 3 (Post-chemo Maintenance Mag + CC-486)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;Phase 2 Cohort 1 (1L Unfit UML Mag + Ven + Aza)Phase 2 Cohort 2 (R/R AML Mag + MEC)Phase 2 Cohort 3 (Post-chemo Maintenance Mag + CC-486)Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts.