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

A Phase Ib, Multicenter, Open-label Platform Study of Select Drug Combinations in Adult Patients With Lower Risk (Very Low, Low, or Intermediate Risk) Myelodysplastic Syndrome

ClinicalTrials.gov Identifier: NCT04810611

Novartis Reference Number: CMBG453E12101

Last Update: Sep 21, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) MDS.

Condition 
Myelodysplastic Syndromes
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Jun 18, 2021
Completion date 
Sep 12, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MBG453
Anti-TIM3 monoclonal antibody
Drug
NIS793
Anti-TGF-β monoclonal antibody
Drug
canakinumab
Anti-IL-1β monoclonal antibody

Eligibility Criteria

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF).

Patients must have a diagnosis prior to participation in the study of IPSS-R very low, low, or intermediate risk MDS with ≤10% bone marrow blasts and one or more of the following:

Symptomatic anemia with hemoglobin <10 g/dL that has relapsed after or is refractory to ESAs (or the patient is intolerant to ESAs)
Symptomatic anemia with hemoglobin <10 g/dL) that is ESA-naive with EPO level ≥ 500 /uL
Thrombocytopenia with platelets <30,000/uL or with clinically significant bleeding or bruising and platelets <50,000/uL
Neutropenia with an absolute neutrophil count (ANC) <500/ µL or with recurrent and/or severe infections and an ANC that is <1000/ µL and amenable to response assessments by International Working Group (IWG) response criteria in myelodysplasia (Cheson et al 2006)
Patients who are refractory to, intolerant of, or ineligible/unable to receive SOC therapeutic options including lenalidomide
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2
Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions' guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study -

Key Exclusion Criteria:

Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
Patients with chronic myelomonocytic leukemia (CMML) or myelodysplastic/myeloproliferative neoplasms (MDS/MPN)
Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or ESAs anytime ≤ 2 weeks (or 5 half-lives, whichever is longer) prior to start of study treatment.
Systemic chronic corticosteroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
For arms containing canakinumab: Patients with ANC < 500 /µL

Study Locations

United States
H Lee Moffitt Cancer Center and Research Institute
Recruiting
Tampa, 33612 - Florida
Contact: Chelsea Conner (813-972-8391) - [email protected] - David Sallman
United States
The Ohio State University Wexner Medical Center
Recruiting
Columbus, 43210 - Ohio
Contact: Jake Morgan (641-239-3316) - [email protected] - Uma Borate
United States
MD Anderson Cancer Center/University of Texas MD Anderson
Recruiting
Houston, 77030 - Texas
Contact: Bailey Mirabella (713-792-7305) - [email protected] - Guillermo Garcia-Manero
United States
Australia
Novartis Investigative Site
Recruiting
Prahran, 3181
Victoria
Australia
China
Novartis Investigative Site
Recruiting
Tianjin, 300020
Tianjin
China
Israel
Novartis Investigative Site
Recruiting
Tel Aviv, 6423906
-
Israel
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Singapore
Novartis Investigative Site
Recruiting
Singapore, 119228
-
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore
Spain
Novartis Investigative Site
Recruiting
Salamanca, 37007
Castilla Y Leon
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08035
Catalunya
Spain

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]