A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
Reason given: Novartis made a decision to early terminate the sabatolimab clinical development program, including the CMBG453C12201 trial, following the negative results from other 2 trials.
Key facts
- Where
- Birmingham, Boston, Charlotte, Chattanooga, Durham, Houston, Iowa City, New Haven, New York, Rochester, and Salt Lake City, United StatesSee the 12 sites
- Phase
- Phase 2
Where in United States
- 25Uni of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- Levine Cancer Insitute Carolinas Healthcare SystemCharlotte, United StatesNo longer taking part
- Chattanooga Onc And Hem Assoc PCChattanooga, United StatesNo longer taking part
- Duke Univ Medical CenterDurham, United StatesNo longer taking part
- MD Anderson Cancer Center - University of TexasHouston, United StatesNo longer taking part
- Uni Of Iowa Hospitals And ClinicsIowa City, United StatesNo longer taking part
- Yale University School Of MedicineNew Haven, United StatesNo longer taking part
- Memorial Sloan KetteringNew York, United StatesNo longer taking part
- Weill Cornell Medicine NY-PresbNew York, United StatesNo longer taking part
- Mayo Clinic - RochesterRochester, United StatesNo longer taking part
- Huntsman Cancer Institute Univ of UtahSalt Lake City, United StatesNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT04150029
- Record updated
- 13 January 2026
- Original description
This trial seeked to extend the preliminary findings of efficacy by evaluating MBG453 in combination with hypomethylating agents (HMA) and also Bcl-2 inhibitor venetoclax.Read full original descriptionShow less
A Phase II Multi-center, Single Arm, Safety and Efficacy Study of MBG453 in Combination With Azacitidine and Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) in Adult Patients Unfit for Chemotherapy
This trial seeked to extend the preliminary findings of efficacy by evaluating MBG453 in combination with hypomethylating agents (HMA) and also Bcl-2 inhibitor venetoclax.
Inclusion: Signed informed consent must be obtained prior to participation in the study; Age ≥ 18 years at the date of signing the informed consent form (ICF); Newly diagnosed with AML based on 2016 WHO classification (Arber et al 2016) and not suitable for intensive chemotherapy defined as: age ≥75, ECOG performance Status 2 or 3, or any of the following comomorbitities: severe cardiac comorbities (including congestive heart failure, LVEF ≤ 50%, chronic stable Angina) , pulmonary comorbidity (DLCO ≤ 65% or FEVI ≤ 65%). moderate hepatic impairment (with total Bilirubin >1.5 to 3x ULN) , renal impairment (eGFR≥ 30 ml/min/1.73m\^2 to <45 ml/min/1.73m\^2), or other comorbidity incompatible with intensive chemotherapy per Investigator assessement and approved by the Novartis Medical monitor); Not planned for hematopoietic stem-cell transplantation (HSCT); Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3.
Exclusion: Prior exposure to TIM-3 directed therapy; Current use or use within 14 days prior to randomization of systemic, steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment; Previous treatment at any time, with any of the following antineoplastic agents, approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating agents (HMAs) such as decitabine or azacitidine; Live vaccine administered within 30 Days prior to randomization; History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their excipients; Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).