DFV890 for Myeloid Diseases

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Novartis Pharmaceuticals

Must not be taking: NLRP3 inhibitors, IL-1 inhibitors, CYP modulators

Disqualifiers: Antineoplastic therapy, Hypersensitivity, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called DFV890 to see if it can help patients with certain low-risk blood diseases. The goal is to find out if the drug is safe and effective, and to determine the best dose for treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take certain cancer treatments, experimental therapies, or medications that affect specific liver enzymes (CYP2C9 and CYP3A) close to the start of the study. It's best to discuss your current medications with the study team to see if any changes are needed.

Research Team

Eligibility Criteria

Adults over 18 with certain low-risk myeloid diseases (like MDS or CMML) who haven't responded well to other treatments can join. They must be able to have bone marrow tests and have a performance status indicating they can still do daily activities. People who've had recent cancer treatments, are sensitive to DFV890 or similar drugs, or take certain other medications cannot participate.

Inclusion Criteria

Patients must have one of the following for eligibility into the study:

I am 18 years old or older.

My CMML is low to intermediate risk and didn't respond well to hydroxyurea or HMAs.

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Exclusion Criteria

History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes

I have not taken medications like DFV890 that target specific inflammation pathways.

I haven't used any blood cell growth boosters in the last week or longer.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dose Optimization

Participants receive DFV890 at varying doses to determine the optimal dose for safety and efficacy

24 weeks

6 cycles of treatment

Dose Expansion

Participants receive the optimized dose of DFV890 to further assess safety and efficacy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

DFV890 (Other)

Trial OverviewThe trial is testing DFV890's safety and effectiveness for myeloid diseases in two parts: one part tries different doses to find the best one, and the second part gives that dose to more people. It looks at how the drug works in the body and its impact on disease symptoms.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: DFV890 low doseExperimental Treatment1 Intervention

DFV890 given as single agent at a low dose

Group II: DFV890 high doseExperimental Treatment1 Intervention

DFV890 given as single agent at a high dose