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Sabatolimab

DRUG6 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Acute Myeloid LeukemiaLeukemia, Myelomonocytic, ChronicMyelodysplastic Syndrome (MDS)Myelodysplastic SyndromesMyelofibrosis

Phase 1

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
TerminatedNCT04097821
Novartis PharmaceuticalsMyelofibrosis
Start: 2019-09-26End: 2024-08-28Updated: 2025-08-07
Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.
TerminatedNCT04623216
Novartis PharmaceuticalsAcute Myeloid Leukemia
Start: 2021-09-14End: 2024-08-22Updated: 2025-10-16
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
WithdrawnNCT05367401
Novartis PharmaceuticalsAcute Myeloid Leukemia, Myelodysplastic Syndromes
Start: 2024-12-20End: 2029-10-26Updated: 2024-04-11

Phase 2

A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants
TerminatedNCT04812548
Novartis PharmaceuticalsMyelodysplastic Syndrome (MDS)
Start: 2021-05-31End: 2023-05-08Updated: 2025-10-09
Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.
Active, not recruitingNCT05201066
Novartis PharmaceuticalsLeukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
Start: 2023-02-13End: 2028-02-14Updated: 2026-01-07

Phase 3

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
TerminatedNCT04266301
Novartis PharmaceuticalsLeukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
Start: 2020-06-08End: 2024-10-02Updated: 2026-01-13

Related Papers

ADORE: an open platform study of ruxolitinib in combination with other novel therapies in patients with myelofibrosis
Blood Advances2025-05-07
TIM-3 Inhibitor Sabatolimab for Patients with Acute Myeloid Leukemia (AML) with Measurable Residual Disease (MRD) Detected after Allogeneic Stem Cell Transplantation (AlloSCT): Preliminary Findings from the Phase Ib/II Stimulus-AML2 Study
Blood2023-11-0212 citations
Molecular Measurable Residual Disease (MRD) Clearance (≤1%) Is Associated with Improved Clinical Outcomes in Patients with Higher-Risk Myelodysplastic Neoplasms (HR-MDS): An Exploratory Analysis of Stimulus-MDS1 in Patients Receiving Sabatolimab or Placebo + Hypomethylating Agent (HMA)
Blood2023-11-024 citations
STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2
Future Oncology2023-03-0131 citations
Primary Results of Stimulus-MDS1: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of TIM-3 Inhibition with Sabatolimab Added to Hypomethylating Agents (HMAs) in Adult Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
Blood2022-11-1518 citations
Disease Characteristics and International Prognostic Scoring Systems (IPSS, IPSS-R, IPSS-M) in Adult Patients with Higher-Risk Myelodysplastic Syndromes (MDS) Participating in Two Randomized, Double-Blind, Placebo-Controlled Studies with Intravenous Sabatolimab Added to Hypomethylating Agents (HMA) (STIMULUS-MDS1 and MDS2)
Blood2022-11-157 citations
Siremadlin, a Human Double Minute-2 (HDM2) Inhibitor, Added to Ruxolitinib after Suboptimal Response to Ruxolitinib Alone in Patients with Myelofibrosis: Results from Part 1 of the Phase 1/2 Adore Study
Blood2022-11-154 citations
P787: SABATOLIMAB (MBG453) COMBINATION TREATMENT REGIMENS FOR PATIENTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES: THE MYELODYSPLASTIC SYNDROMES STUDIES IN THE STIMULUS IMMUNO-MYELOID CLINICAL TRIAL PROGRAM
HemaSphere2022-06-011 citations
Sabatolimab (MBG453) Combination Treatment Regimens for Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS): The MDS Studies in the Stimulus Immuno-Myeloid Clinical Trial Program
Blood2021-11-0512 citations
Adore: A Randomized, Open-Label, Phase 1/2 Open-Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Patients with Myelofibrosis
Blood2020-11-0510 citations
The STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML)
Blood2020-11-0427 citations