Actively Recruiting
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Led by Disc Medicine, Inc · Updated on 2026-03-04
60
Participants Needed
14
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).
CONDITIONS
Official Title
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of signing the informed consent form
- Meet revised 2022 World Health Organization criteria for diagnosis of polycythemia vera
- Screening blood counts with hematocrit less than 45% or less than 48% if followed by phlebotomy within 2 weeks
- White blood cells between 4000/µL and 20,000/µL, platelets between 100,000/µL and 1,000,000/µL
- At least 3 phlebotomies in the 26 weeks before screening or at least 5 in the 52 weeks before screening, with at least 1 within 12 weeks prior
- If receiving cytoreductive therapy, must have been on stable dose for at least 2 months and therapy for at least 6 months or have decreasing dose with approval
- If treated with phlebotomy alone, must have stopped cytoreductive therapy 6 months before screening
- Eastern Cooperative Oncology Group performance status 0 or 1, or 2 with approval
- If male with female partner(s) of childbearing potential, agree to use effective contraception during study and for 120 days after last dose
- If female, must be postmenopausal, surgically sterile, or agree to use effective contraception during study and for 120 days after last dose
- Negative pregnancy test for females of childbearing potential
- Able to understand study aims and provide written informed consent
- Able to comply with all study procedures
You will not qualify if you...
- Clinically significant laboratory abnormalities at screening
- Require phlebotomy at hematocrit levels less than 45%
- Significant blood clots within 2 months before treatment
- Active or chronic bleeding within 6 months before treatment
- Severe kidney dysfunction with estimated glomerular filtration rate below 30 mL/min/1.73 m2
- History of invasive cancers within 5 years except some localized cured cancers
- Certain early skin cancers unless adequately treated before entry
- Use of busulfan, pipobroman, or phosphorus-32 within 7 months before screening
- Major surgery within 8 weeks before screening or incomplete recovery
- Allergic reactions or anaphylaxis to investigational product or foods
- History of alcohol dependence or excessive use
- Active HIV, hepatitis B or C infections
- Other medical or psychiatric conditions that pose unacceptable risk
- Conditions or medications that interfere with data interpretation, including recent major psychiatric exacerbations
- Pregnant or breastfeeding females
- Participation in other investigational studies within 30 days or 5 drug half-lives
- Previous use of certain hepcidin-inducing agents not allowed without sponsor discussion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCLA Health
Los Angeles, California, United States, 90095
Actively Recruiting
4
Keck Medicine of USC - Cancer Clinic- Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
5
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
6
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Siteman Cancer Center - Washington University St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Atrium Health - Levine Cancer Center
Charlotte, North Carolina, United States, 28204
Actively Recruiting
9
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
10
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
11
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Washington - Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
D
Disc Medicine Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here