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;
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 may be enrolled into the corresponding Phase 2 cohorts;
Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts.
Note: Currently, this study is only open to enrollment into Phase 2 Cohort 2 and Safety Run-in Cohort 3. All other cohorts are closed to screening and enrollment.
| Condition | Myeloid Malignancies |
|---|---|
| Treatment | cytarabine, etoposide, Mitoxantrone, Azacitidine, CC-486, venetoclax, Magrolimab |
| Clinical Study Identifier | NCT04778410 |
| Sponsor | Gilead Sciences |
| Last Modified on | 22 September 2023 |
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