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NCT05552469
Dose Optimization and Expansion Study of DFV890 in Adult Patients With Myeloid Diseases
Phase 1 trial testing DFV890 in Myeloid Diseases in 62 participants. Participants enrolled and being followed up; not accepting new ones.
13 January 2027
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 8 May 2023 |
| Primary completion | 13 January 2027 |
| Estimated completion | 13 January 2027 |
| Sites | 26 locations across France, Hong Kong, Italy, United Kingdom, Germany, Singapore, United States, Spain |
Drugs / interventions tested
- DFV890 — full drug profile →
Conditions studied
- Myeloid Diseases — all drugs for Myeloid Diseases →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT05552469
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06031844 — A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Parti · Phase 2 · completed
- NCT04886258 — Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis · Phase 2 · completed
- NCT04868968 — Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS · Phase 2 · completed
- NCT04382053 — Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia · Phase 2 · completed
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05552469 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
- Last refreshed: 27 March 2026
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