Actively Recruiting
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
Led by Marina Kremyanskaya · Updated on 2025-04-06
10
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to assess the safety and tolerability of administrating mutated-CALR peptide Vaccine to patients with MPN. The researchers plan to enroll 10 patients over a 12 month period. Maximum length of participation in 80 weeks. Patients will be asked to complete questionnaires, bone marrow biopsies, research lab collection, and standard of care lab draw. This research will be taking place only at The Mount Sinai Hospital, specifically at the Ruttenberg Treatment Center.
CONDITIONS
Official Title
Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of informed consent
- Confirmed diagnosis of chronic phase MPN including previously treated or relapsed/refractory high risk ET or low to intermediate 1 risk PMF or ET-MF
- Verified mutation in CALR exon 9
- Performance status 2 or less
- Adequate organ function including neutrophil count ≥ 1000/mm3, platelet count ≥ 50,000/mm3, creatinine ≤ 2.5 mg/dL, total bilirubin ≤ 2 mg/dL (≤ 3 mg/dL if Gilbert Syndrome), and transaminases < 3 times institutional upper limit
- Females of childbearing potential must have a negative pregnancy test within 10-14 days prior to study medication and agree to use two forms of birth control starting at least 4 weeks before first vaccine dose and ongoing pregnancy testing
- Ability to understand and sign informed consent
- Ability to comply with study visits and protocol requirements
- Stable dose of hydroxyurea for at least 8 weeks prior to week 1 if receiving cytoreductive therapy
You will not qualify if you...
- History of other invasive malignancy within past 3 years except non-melanoma skin cancer, localized cured prostate cancer, or early stage breast cancer on hormone replacement therapy
- Active autoimmune disease
- Uncontrolled serious infection
- Known immunodeficiency
- Pregnant or breastfeeding women
- Unwillingness to use contraception
- Current use of immunosuppressive medications including steroids
- Current use of JAK inhibitors
- Current use of interferon (anagrelide use permitted)
- Treatment with other experimental drugs within 30 days before week 1
- Treatment with any MPN-directed therapy within 5 half-lives before week 1 unless noted
- Any significant psychiatric or medical condition per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Marina Kremyanskaya, MD, PhD
CONTACT
G
Gabriela Bello
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
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