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DISC-0974 for Myelofibrosis

Phase 1 & 2

Recruiting

Research Sponsored by Disc Medicine, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2

For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4 (intermediate-2 risk) or ≥ 5 (high-risk) primary MF, post-PV MF, and/or post-ET MF, as confirmed in the most recent local bone marrow biopsy report, according to World Health Organization (WHO) 2016 criteria

Must not have

Known allergic reactions, anti-drug antibody formation, inadequately controlled heart disease, active Hepatitis B or C, or HIV with detectable viral load

Treatment History exclusions including recent iron chelation therapy and change in anticoagulant therapy regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial will study how safe and tolerable a new drug is, as well as how it affects anemia in people with myelofibrosis.

Who is the study for?

Adults over 18 with myelofibrosis and anemia can join this trial. They should have a certain level of disease severity, be able to perform daily activities, and have kidneys that work well enough. Participants need to stop some treatments before joining and meet specific blood count criteria. People who've had recent major surgery or other cancers (with exceptions), active infections, or severe heart problems cannot join.

What is being tested?

The study is testing DISC-0974's safety and how it affects the body in patients with myelofibrosis-related anemia. It's an early-stage trial where everyone gets the drug; there are no comparison groups.

What are the potential side effects?

Since DISC-0974 is still being studied, potential side effects aren't fully known yet but may include typical drug reactions like nausea, headaches, allergic responses or more specific effects related to its action on the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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My bone marrow biopsy shows I have a high-risk form of myelofibrosis.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe allergies, heart issues, active Hepatitis B or C, or uncontrolled HIV.

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I haven't had recent iron removal treatment or changed my blood thinner regimen.

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I do not have any untreated fungal, bacterial, or viral infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2a: ExpansionExperimental Treatment1 Intervention

In the Phase 2a (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.

Group II: Phase 1b: Dose EscalationExperimental Treatment1 Intervention

In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DISC-0974

2021

Completed Phase 1

~50

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Disc Medicine, IncLead Sponsor

5 Previous Clinical Trials

413 Total Patients Enrolled

Will Savage, MD PhDStudy DirectorDisc Medicine

4 Previous Clinical Trials

371 Total Patients Enrolled

Media Library

DISC-0974 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05320198 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: Phase 1b: Dose Escalation, Phase 2a: Expansion

Myelodysplastic Syndrome Clinical Trial 2023: DISC-0974 Highlights & Side Effects. Trial Name: NCT05320198 — Phase 1 & 2

DISC-0974 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05320198 — Phase 1 & 2

~0 spots leftby Oct 2024

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