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NCT05552469

Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases

Active, enrolled Phase 1 Last updated 27 March 2026
What this trial tests

Phase 1 trial testing DFV890 in Myeloid Diseases in 62 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
8 May 2023
Primary endpoint
13 January 2027
13 January 2027

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment62
Start date8 May 2023
Primary completion13 January 2027
Estimated completion13 January 2027
Sites26 locations across France, Hong Kong, Italy, United Kingdom, Germany, Singapore, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with Myeloid Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study CDFV890G12101 is an open-label, phase 1b, multicenter study with a randomized two-dose optimization part, and a dose expansion part consisting of three groups evaluating DFV890 in patients with myeloid diseases. The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy and recommended dose for single agent DFV890 in patients with lower risk (LR: very low, low or intermediate risk) myelodysplastic syndromes (LR MDS), lower risk chronic myelomonocytic leukemia (LR CMML) and High-Risk Clonal Cytopenia of Undetermined Significance (HR CCUS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
    Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
  2. NLRP3 and cancer: Pathogenesis and therapeutic opportunities.
    Tengesdal IW, Dinarello CA, Marchetti C. · · 2023 · cited 37× · PMID 37866732 · DOI 10.1016/j.pharmthera.2023.108545
  3. The discovery of NLRP3 and its function in cryopyrin-associated periodic syndromes and innate immunity.
    Putnam CD, Broderick L, Hoffman HM. · · 2024 · cited 27× · PMID 38146057 · DOI 10.1111/imr.13292
  4. Screening NLRP3 drug candidates in clinical development: lessons from existing and emerging technologies.
    Tengesdal IW, Banks M, Dinarello CA, Marchetti C. · · 2024 · cited 21× · PMID 39188718 · DOI 10.3389/fimmu.2024.1422249
  5. Inflammasomes in neurodegenerative diseases.
    Wang Q, Yang S, Zhang X, Zhang S, et al · · 2024 · cited 13× · PMID 39710713 · DOI 10.1186/s40035-024-00459-0
  6. Bone marrow microenvironment in myelodysplastic neoplasms: insights into pathogenesis, biomarkers, and therapeutic targets.
    Bahmani F, Shayanmanesh M, Safari M, Alaei A, et al · · 2025 · cited 3× · PMID 40349084 · DOI 10.1186/s12935-025-03793-z
  7. Myelodysplastic Neoplasms (MDS): Pathogenesis and Therapeutic Prospects.
    Li X, Zou C, Xiang X, Zhao L, et al · · 2025 · cited 2× · PMID 40563403 · DOI 10.3390/biom15060761
  8. Molecular Insights and Therapeutic Advances in Low-Risk Myelodysplastic Neoplasms: A Clinical Review.
    Dhillon V, Maciejewski J, Balasubramanian SK. · · 2025 · cited 1× · PMID 41300977 · DOI 10.3390/cancers17223610

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05552469.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing