NCT05367401

A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants

A Phase Ib/II, Open Label, Proof-of-concept Study of Sabatolimab and Magrolimab-based Therapy for Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the safety and preliminary efficacy of sabatolimab in combination with magrolimab and azacitidine in adult participants with 1L unfit Acute Myeloid Leukemia (AML) or with 1L higher risk Myelodysplastic Syndromes (MDS), and sabatolimab in combination with magrolimab in participants with relapsed or refractory (R/R) AML.

Detailed description

The primary purpose of the Safety run-in is to rule out excessive toxicity and investigate safety of the combination of sabatolimab with azacitidine and magrolimab in previously untreated participants with higher-risk MDS and unfit AML. The primary purpose of the combined Safety Run-in and Expansion is to assess the preliminary efficacy of the combination of sabatolimab with magrolimab with (cohort 1 and 2) or without (cohort 3) azacitidine in terms of achieving complete remission in 3 different indications: * Previously untreated participants with AML, who are unfit for intensive chemotherapy (1L unfit AML - cohort 1), * Previously untreated participants with higher-risk MDS (1L higher risk MDS - cohort 2), * Participants with R/R AML after having been previously treated with only first line venetoclax in combination with hypomethylating agent (VEN+HMA) (R/R AML - cohort 3).

Conditions

• Myelodysplastic Syndromes
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Sabatolimab	Solution for intravenous infusion
DRUG	Magrolimab	Solution for intravenous infusion
DRUG	Azacitidine	Solution for subcutaneous injection or intravenous infusion

Timeline

• Start date: 2024-12-20
• Primary completion: 2029-10-26
• Completion: 2029-10-26
• First posted: 2022-05-10
• Last updated: 2024-04-11

Regulatory

• FDA-regulated drug study