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New drug DFV890 takes on Hard-to-Treat blood cancers

NCT ID NCT05552469

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This early-stage trial tests a new drug called DFV890 in about 62 adults with low-risk myelodysplastic syndromes, low-risk chronic myelomonocytic leukemia, or high-risk clonal cytopenia of undetermined significance. The main goals are to check the drug's safety, find the best dose, and see if it can reduce the need for blood transfusions. Participants will be closely monitored for side effects and how their disease responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DFV890
What this could lead to
If successful, this could point toward a new treatment option for certain myeloid blood disorders that currently have limited therapies.
What could go wrong
This is an early Phase 1b trial with only 62 participants, so safety and the right dose are still being figured out. It may not lead to an approved treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

71 people

The number who actually took part.

Started

May 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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. 3. changes for dose expansion (applicable as of amendment 3): 1. LR MDS with ≤ 10% bone marrow blasts, IPSS-R score of ≤ 3.5, transfusion independent (TID) status as per IWG 2006 criteria (requiring \<4U pRBC in 8 weeks), clinically meaningful cytopenia(s) and no or limited (\<4 months) prior therapy for MDS. 2. LR CMML patients with symptomatic cytopenias and/or constitutional symptoms refractory, intolerant or unsuitable for standard first-line therapy. 3. HR-CCUS: Diagnosis of high-risk CCUS by clonal hematopoiesis risk score (CHRS) with clinically meaningful cytopenias and no prior therapy for a myeloid neoplasm. 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. a. For TID LR MDS in Dose Expansion Phase only (applicable as of amendment 03): 1. Prior therapy for MDS administered for \>4 months (ESA and luspatercept administered for ≤4 months will be allowed if washout period followed) 2. Concurrent malignancy requiring active systemic therapy 3. Prior or concurrent cytotoxic chemotherapy for MDS at any time 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 6-7, 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: a. 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 b. 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. 6\. Dose expansion only: Poor CYP2C9 metabolizers defined as genotype of the CYP2C9 \*3/\*3 or CYP2C9 \*2/\*3 allele combinations are excluded. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

chronic myelomonocytic leukemia myelodysplastic syndrome Myelodysplastic Syndromes myeloid neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloid diseases

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • H Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10065, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    London, SE5 9RS, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Sidney Kimmel CCC At JH

    Baltimore, Maryland, 21231, United States

  • Stanford Cancer Center

    Stanford, California, 94305, United States

  • Univ of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • Vanderbilt University Medical Ctr

    Nashville, Tennessee, 37232, United States

  • Weill Cornell Medicine NY-Presb

    New York, New York, 10021, United States

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