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Anti-metabolites

Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

Phase 1

Waitlist Available

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of magrolimab, a new drug, in people with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. The primary objectives are to confirm the safety and tolerability of magrolimab and to evaluate the efficacy of magrolimab in achieving complete remission.

Eligible Conditions

Blood Cancers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Remission (CR) Rate For Participants With AML

Complete Remission Rate for Participants with MDS

Duration of Complete Remission (DCR) in Participants with AML and MDS

+1 more

Secondary study objectives

12-week RBC Transfusion Independence Rates

Duration of Response (DOR) for Participants with AML

Duration of Response for Participants with MDS

+7 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782

67%

Abdominal pain

33%

Infusion related reaction

33%

Performance status decreased

33%

Pyrexia

33%

Pain

33%

Gait disturbance

33%

Hypotension

33%

Hyperhidrosis

33%

Gastrooesophageal reflux disease

33%

Headache

33%

Deafness

33%

Malignant neoplasm progression

33%

Vomiting

33%

Pollakiuria

33%

Diarrhoea

33%

Rash maculo-papular

33%

Lactic acidosis

33%

Nausea

33%

Aspartate aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Blood bilirubin increased

33%

Blood lactate dehydrogenase increased

33%

Mental disorder

33%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Magrolimab Priming Dose Only

Magrolimab 45 mg/kg

Magrolimab 10 mg/kg

Magrolimab 20 mg/kg

Magrolimab 30 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Treatment-naive Unfit (TNU) Dose Expansion CohortExperimental Treatment2 Interventions

Participants will receive 1 mg/kg magrolimab twice weekly for Cycle 1; 15 mg/kg weekly for Cycle 1 Day 8; 30 mg/kg weekly through end of cycle 2; and then 30 mg/kg every 2 weeks starting Cycle 3 up to end of the study + azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle.

Group II: Treatment-naive Unfit (TNU) Dose Evaluation CohortExperimental Treatment2 Interventions

Participants will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Day 11, 15, 22, and then weekly starting Cycle 2 up to end of the study + azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle.

Group III: RolloverExperimental Treatment1 Intervention

Participants on a previous AML Phase 1 trial (SCI-CD47-002; NCT02678338) with clinical benefit on magrolimab treatment will receive the same dose level (0.1 mg/kg up to 30.0mg/kg based on the cohort to which the participant was assigned) twice weekly or may transition to once weekly dosing at the discretion of the Investigator and approval from Gilead.

Group IV: RBC transfusion-dependent low-risk MDS, Safety Run-in PhaseExperimental Treatment2 Interventions

Participants will receive 1 mg/kg magrolimab on Cycle 1 Day 1; 30 mg/kg on Cycle 1 Days 8, 15, and 22; and 60 mg/kg every 4 weeks starting on Cycle 2 Day 1 and thereafter up to end of the study. For participants who do not respond after Cycle 2, azacitidine 75 mg/m\^2 may be added on subsequent cycles (ie starting at Cycle 3) on Days 1 to 5 of each cycle.

Group V: RBC transfusion-dependent low-risk MDS, Expansion PhaseExperimental Treatment2 Interventions

Participants will receive 1 mg/kg magrolimab on Cycle 1 Day 1; at 30 mg/kg on Cycle 1 Days 8, 15, and 22; and 60 mg/kg every 4 starting on Cycle 2 Day 1 and thereafter up to end of the study + azacitidine 75 mg/m\^2 on Days 1 to 5 of each cycle.

Group VI: R/R Safety CohortExperimental Treatment1 Intervention

Participants will receive 1 mg/kg magrolimab twice weekly for Cycle 1 Week 1 (Day 1 and 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11 and 15; and 30 mg/kg weekly thereafter starting Cycle 3 up to end of the study.

Group VII: R/R MDS Magrolimab Monotherapy CohortExperimental Treatment1 Intervention

Participants will receive 1 mg/kg magrolimab on Cycle 1 (Days 1, 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Day 11, 15, 22, weekly on Cycle 2, and then biweekly starting Cycle 3 up to end of the study.

Group VIII: R/R Expansion Cohort:Experimental Treatment2 Interventions

Participants will receive 1 mg/kg magrolimab twice weekly for Cycle 1 Week 1 (Day 1 and Day 4); 15 mg/kg on Cycle 1 Day 8; 30 mg/kg on Cycle 1 Days 11 and 15; 30 mg/kg weekly on Cycle 1 Day 22 through end of Cycle 2, then 30 mg/kg every 2 weeks starting Cycle 3 up to end of the study + azacitidine 75 mg/m\^2 on Days 1 to 7 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magrolimab

2022

Completed Phase 2

~220

Azacitidine

2012

Completed Phase 3

~1440