sabatolimab (MBG453) / Novartis 
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 0 Diseases   14 Trials   14 Trials   139 News 
18 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
sabatolimab (MBG453) / Novartis
STIMULUS-MDS2, NCT04266301 / 2019-002089-11: 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)

Calendar Jan 2024 - Dec 2024: Data from STIMULUS-MDS 2 trial for MDS
Active, not recruiting
3
530
Europe, Canada, Japan, US, RoW
Sabatolimab, MBG453, Azacitidine, Placebo
Novartis Pharmaceuticals
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
10/24
10/24
2019-000439-14: A study of MBG453 in combination with azacitidine and venetoclax in AML patients unfit for chemotherapy

Not yet recruiting
2
86
Europe
Sabatolimab, Venetoclax, Azacitidine, MBG453, Concentrate for solution for infusion, Film-coated tablet, Powder for suspension for injection, Venclyxto, Azacitidin EVER Pharma 25 mg/ml
Novartis Pharma AG, NOVARTIS PHARMA AG, Novartis Pharma AG
Acute Myeloid Leukemia (AML) in adult patients unfit for chemotherapy, Acute Myeloid Leukemia (AML), Diseases [C] - Cancer [C04]
 
 
STIMULUS-MDS1, NCT03946670 / 2018-004479-11: A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).

Hourglass Jul 2022 - Dec 2022 : Data read-out from STIMULUS MDS-1 trial for MDS
Checkmark Completion of enrollment of STIMULUS-MDS-1 trial for high risk MDS
Sep 2020 - Sep 2020: Completion of enrollment of STIMULUS-MDS-1 trial for high risk MDS
Completed
2
127
Europe, Canada, Japan, US, RoW
MBG453, Sabatolimab, Placebo, Hypomethylating agents
Novartis Pharmaceuticals
Myelodysplastic Syndromes
04/22
07/24
NCT04823624: MBG453 in Lower Risk MDS

Recruiting
2
20
US
MBG453
Massachusetts General Hospital, Novartis
Myelodysplastic Syndromes
06/24
01/26
2021-004422-30: 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 Estudio de extensión para pacientes que hayan completado un estudio previo de sabatolimab (MBG453) promocionado por Novartis y para los que, a criterio del investigador, sea beneficioso continuar el tratamiento con este fármaco.

Ongoing
2
70
Europe
sabatolimab, MBG453, Concentrate for solution for infusion, Film-coated tablet, Powder for suspension for injection, Venclyxto 50 mg film-coated tablets, Venclyxto 100 mg film-coated tablets, Venclyxto 10 mg film-coated tablets, Azacitidin EVER Pharma
Novartis Farmacéutica, S.A., Novartis Pharma AG, Novartis Pharma AG
intermediate, high or very high risk MDS in adult patientschronic Myelomonocytic Leukemia - 2 (CMML-2)Acute Myeloid Leukemia (AML) in adult patients unfit for chemotherapy Pacientes adultos con síndrome mielodisplásico (SMD) de riesgo intermedio, alto o muy alto, pacientes con Leucemia Mielomonocítica Crónica de tipo 2 (LMMC-2) y pacientes adultos con Leucemia Mieloide Aguda (LMA) no candidatos a quimioterapia., intermediate, high or very high risk MDSChronic Myelomonocytic Leukemia - 2Acute Myeloid Leukemia (AML) Síndrome mielodisplásico (SMD) de riesgo intermedio, alto o muy alto.Leucemia Mielomonocítica Crónica de tipo 2 (LMMC-2.Leucemia Mieloide Aguda (LMA), Diseases [C] - Cancer [C04]
 
 
STIMULUS-MDS3, NCT04812548 / 2020-003669-21: A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants

Terminated
2
20
Europe
sabatolimab, MBG453, azacitidine, venetoclax
Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
05/23
05/23
STIMULUS MDS-US, NCT04878432: : Sabatolimab Added to HMA in Higher Risk MDS

Active, not recruiting
2
39
US
MBG453, sabatolimab, Azacitidine, Decitabine, INQOVI (oral decitabine)
Novartis Pharmaceuticals
Myelodysplastic Syndrome (MDS)
09/23
10/24
STIMULUS-AML-1, NCT04150029: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

Hourglass Jan 2023 - Dec 2023 : Data from STIMULUS-AML1 trial for AML
Active, not recruiting
2
90
Europe, Canada, Japan, US, RoW
MBG453, Sabatolimab, Venetoclax, Azacitidine
Novartis Pharmaceuticals
Acute Myeloid Leukemia
10/24
10/24
NCT05201066: 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.

Recruiting
2
70
Europe, Canada, Japan, US, RoW
decitabine, spartalizumab, PDR001, sabatolimab, MBG453, azacitidine, venetoclax, INQOVI (oral decitabine)
Novartis Pharmaceuticals
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
02/28
02/28
ACTRN12621001265864p: AMLM26/T5 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - MBG453 OR MBG453 and Azacitidine

Not yet recruiting
1/2
60
 
Australasian Leukaemia & Lymphoma Group, Australasian Leukaemia & Lymphoma Group
acute myeloid leukaemia
 
 
ACTRN12621001265864: AMLM26/T5 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - MBG453 OR MBG453 and Azacitidine

Recruiting
1/2
60
 
Australasian Leukaemia & Lymphoma Group, Australasian Leukaemia & Lymphoma Group
acute myeloid leukaemia
 
 
ADORE, NCT04097821 / 2019-000373-23: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Calendar Jan 2024 - Dec 2024: From ADORE trial for myelofibrosis
Active, not recruiting
1/2
45
Europe, Canada, RoW
Ruxolitinib, INC424, Jakavi, Siremadlin, HDM201, Crizanlizumab, SEG101, Sabatolimab, MBG453, Rineterkib, LTT462, NIS793
Novartis Pharmaceuticals
Myelofibrosis
05/23
08/24
STIMULUS-AML2, NCT04623216 / 2020-000869-17: Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.

Active, not recruiting
1/2
24
Europe
Sabatolimab, MBG453, Azacitidine
Novartis Pharmaceuticals
Acute Myeloid Leukemia
12/24
12/24
NCT05367401: A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants

Withdrawn
1/2
63
NA
Sabatolimab, MBG453, Magrolimab, GS-4721, Azacitidine
Novartis Pharmaceuticals
Myelodysplastic Syndromes, Acute Myeloid Leukemia
10/29
10/29
NCT03961971: Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

Active, not recruiting
1
16
US
MBG453, spartalizumab, stereotactic radiosurgery
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Novartis Pharmaceuticals
Glioblastoma Multiforme
11/22
09/25
CPDR001X2105, NCT03066648: Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

Checkmark Data from P1b portion of trial in combination with MBG453 and decitabine for AML/MDS at EHA 2020
Jun 2020 - Jun 2020: Data from P1b portion of trial in combination with MBG453 and decitabine for AML/MDS at EHA 2020
Checkmark In combination with PDR001 for AML or high risk MDS
Feb 2017 - Feb 2017: In combination with PDR001 for AML or high risk MDS
Completed
1
241
Europe, US, RoW
Decitabine, 5-aza-2'-deoxycytidine, PDR001, spartalizumab, MBG453, sabatolimab, Azacitidine, 5-azacytidine
Novartis Pharmaceuticals
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Preleukemia, Bone Marrow Diseases, Hematologic Diseases, Chronic Myelomonocytic Leukemia
09/23
09/23
NCT03940352: HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

Active, not recruiting
1
52
Europe, US, RoW
HDM201, MBG453, Venetoclax
Novartis Pharmaceuticals
Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS)
07/24
07/24
NCT04810611: Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

Terminated
1
33
Europe, US, RoW
MBG453, sabatolimab, NIS793, canakinumab, ACZ885
Novartis Pharmaceuticals
Myelodysplastic Syndromes
04/24
04/24

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