NCT05025488 Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
| NCT ID | NCT05025488 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Marina Kremyanskaya |
| Condition | Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2023-04-04 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Subjects must be ≥18 years of age at the time of signing the informed consent form. * Confirmed diagnosis of chronic phase MPN: * Previously treated or relapsed/refectory high risk ET * Low to intermediate 1 risk (DIPSS 0-1) PMF or ET-MF * Verified mutation in CALR exon 9 * PS ≤ 2 * Adequate organ function: * Absolute neutrophil count ≥ 1000/mm3, * Platelet count ≥ 50,000/mm3, * Creatinine ≤ 2.5 mg/dL, * Total bilirubin ≤ 2 mg/dL, (except in patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL) * Transaminases \< 3 times above the upper limits of the institutional normal. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to starting study medication and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks prior to first dose of vaccine. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. * Ability to understand and the willingness to sign a written informed consent. * Ability to adhere to the study visit schedule and all protocol requirements. * Subjects receiving cytoreductive therapy with hydroxyurea must be on a stable dose for at least 8 weeks prior to week 1. Exclusion Criteria: * Other invasive malignancy in the past 3 years except non-melanoma skin cancer, localized cured prostate cancer and early stage breast cancer on HRT. * Active autoimmune disease. * Uncontrolled serious infection. * Known immunodeficiency. * Pregnant and breastfeeding women. * Not willing to use contraception. * Current use of immunosuppressive medications including steroids. * Current JAK inhibitor use. * Current use of IFN (use of anagrelide is permitted). * Treatment with other experimental drugs within 30 days of week 1. * Treatment with any MPN directed therapy unless otherwise noted within 5 half-lives of week 1. * Any significant psychiatric/medical condition per investigators judgment.
Contact & Investigator
Marina Kremyanskaya, MD, PhD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05025488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05025488 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05025488 currently recruiting?
Yes, NCT05025488 is actively recruiting participants. Contact the research team at marina.kremyanskaya@mssm.edu for enrollment information.
Where is the NCT05025488 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05025488 clinical trial?
NCT05025488 is sponsored by Marina Kremyanskaya. The principal investigator is Marina Kremyanskaya, MD, PhD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 10 participants.