MBG453

DRUG11 trials

Sponsors

Novartis Pharma AG, Novartis Pharmaceuticals, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Massachusetts General Hospital

Conditions

Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)Advanced MalignanciesBone Marrow DiseasesChronic Myelomonocytic LeukemiaGlioblastoma MultiformeHematologic DiseasesHigh-risk Myelodysplastic Syndrome (MDS)

Phase 1

Phase I-Ib/II Study of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies

TerminatedNCT02608268

Novartis PharmaceuticalsAdvanced Malignancies

Start: 2015-11-23End: 2022-08-30Updated: 2023-12-06

Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

CompletedNCT03066648

Novartis PharmaceuticalsBone Marrow Diseases, Chronic Myelomonocytic Leukemia, Hematologic Diseases +5

Start: 2017-07-06End: 2023-09-08Updated: 2025-05-18

HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

TerminatedNCT03940352

Novartis PharmaceuticalsAcute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS)

Start: 2019-06-24End: 2024-08-20Updated: 2025-10-10

Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

Active, not recruitingNCT03961971

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsGlioblastoma Multiforme

Start: 2020-02-18End: 2026-09-30Updated: 2025-09-10

Study of Select Combinations in Adults With Myelofibrosis

WithdrawnNCT04283526

Novartis PharmaceuticalsMyelofibrosis, PMF, Post-Essential Thrombocythemia Myelofibrosis +2

Start: 2020-11-30End: 2024-04-11Updated: 2021-03-04

Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

TerminatedNCT04810611

Novartis PharmaceuticalsMyelodysplastic Syndromes

Start: 2021-06-18End: 2024-04-19Updated: 2025-10-10

Phase 2

A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).

TerminatedNCT03946670

Novartis PharmaceuticalsMyelodysplastic Syndromes

Start: 2019-06-04End: 2024-07-15Updated: 2026-01-13

A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

TerminatedNCT04150029

Novartis PharmaceuticalsAcute Myeloid Leukemia

Start: 2020-09-01End: 2024-10-25Updated: 2026-01-13

MBG453 in Lower Risk MDS

TerminatedNCT04823624

Massachusetts General HospitalMyelodysplastic Syndromes

Start: 2022-01-27End: 2025-11-01Updated: 2026-02-27

STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS

TerminatedNCT04878432

Novartis PharmaceuticalsMyelodysplastic Syndrome (MDS)

Start: 2022-03-17End: 2024-09-01Updated: 2025-10-16

An open-label, multicenter, 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 recruitingCTIS2024-515281-14-00

Novartis Pharma AGhigh or very high risk MDS in adult patients chronic Myelomonocytic Leukemia - 2 (CMML-2) Acute Myeloid Leukemia (AML) in adult patients unfit for chemotherapy, intermediate

Start: 2023-02-13Target: 18Updated: 2025-09-30

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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

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Efficacy and Safety of Sabatolimab (MBG453) in Combination with Hypomethylating Agents (HMAs) in Patients (Pts) with Very High/High-Risk Myelodysplastic Syndrome (vHR/HR-MDS) and Acute Myeloid Leukemia (AML): Final Analysis from a Phase Ib Study

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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

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Allogeneic Hematopoietic Cell Transplantation Outcomes of Patients with R/R AML or Higher-Risk MDS Treated with the TIM-3 Inhibitor MBG453 (Sabatolimab) and Hypomethylating Agents

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