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Optimizing and expanding the use of DFV890 for adults with myeloid diseases

A Phase 1b, Open Label, Multi-center, Dose Optimization and Dose Expansion Study to Assess the Safety and Efficacy of DFV890 in Adult Patients With Myeloid Diseases

Phase 1 Interventional Novartis · NCT05552469

This study is testing a new treatment called DFV890 to see if it is safe and effective for adults with certain blood cancers like myelodysplastic syndromes and chronic myelomonocytic leukemia.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment80 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionscanakinumab, chemotherapy
Locations22 sites (Stanford, California and 21 other locations)
Trial IDNCT05552469 on ClinicalTrials.gov

What this trial studies

This is an open-label, phase 1b multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of DFV890 in adult patients diagnosed with lower risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). The study includes a randomized two-dose optimization part and a dose expansion part, where eligible patients will receive DFV890 for a minimum of 24 weeks. Participants will undergo bone marrow sampling at screening and select timepoints to monitor treatment effects and safety. The goal is to determine the optimal dose of DFV890 that is both safe and effective for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with very low, low, or intermediate risk myelodysplastic syndromes or chronic myelomonocytic leukemia who have failed to respond to or tolerate previous treatments.

Not a fit: Patients with higher risk myeloid diseases or those who are not candidates for bone marrow procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with lower risk myeloid diseases who have not responded to existing therapies.

How similar studies have performed: While this approach is novel in the context of DFV890 for these specific conditions, similar studies have shown promise in optimizing treatments for myeloid diseases.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Patients must be ≥ 18 years of age at the time of signing the informed consent form (ICF)
2. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
3. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutions guidelines and must be willing to undergo a bone marrow aspirate.
4. Patients must have one of the following for eligibility into the study:

   1. In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Myelodysplastic Syndrome (LR MDS) who failed to respond to or did not tolerate ESAs or luspatercept or HMAs and patients with del 5q who failed to respond to or did not tolerate lenalidomide; or
   2. In dose optimization and expansion: IPSS-R defined very low, low or intermediate risk Chronic Myelomonocytic Leukemia (LR CMML) who failed to respond to or did not tolerate hydroxyurea or HMAs.

Key Exclusion Criteria:

1. Systemic antineoplastic therapy (including cytotoxic chemotherapy, alpha-interferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 28 days or 5 half-lives, whichever is longer, and recovered from the toxicities before the first dose of study treatment. For patients that received antibodies the washout period is 4 weeks prior to study treatment.
2. History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
3. Patients who have previously been treated with agents that have the same mechanism of action as DFV890 as defined in Table 6-8, list of prohibited medications (e.g., drugs targeting the NLRP3 inflammasome pathway and the IL-1 pathway (canakinumab and anakinra)).
4. Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents anytime ≤ 1 week (or 5 half lives, whichever is longer) prior to start of study treatment.
5. Patients receiving:

   1. concomitant medications that are known to be modulators of cytochrome P450 enzymes CYP2C9 and/or CYP3A (specifically strong or moderate inducers of CYP2C9, strong inducers of CYP3A enzymes, strong inhibitors of CYP2C9 and/or strong or moderate dual inhibitors of CYP2C9/CYP3A); and
   2. patients, who are poor CYP2C9 metabolizers receiving concomitant medications known to be strong or moderate inhibitors of CYP3A, whose concomitant medications cannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to start of study treatment and for duration of the study. See Section 6.8 and list of prohibited drugs in Appendix 8 for more details.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Stanford, California and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Myeloid DiseasesMDSCMMLNLRP3Myelodysplastic SyndromesChronic Myelomonocytic Leukemiainflammasome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.