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New treatment option for Myelofibrosis
Official title Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
ClinicalTrials.gov ID: NCT05025488
What this study is testing
What is Peptide-based vaccine?
Peptide-based vaccine is an investigational medicine, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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
You likely can't join if
- 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.
See the full eligibility criteria
- people 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...
- Ability to understand and the willingness to sign a written informed consent.
- Ability to adhere to the study visit schedule and all protocol requirements.
- people receiving cytoreductive therapy with hydroxyurea must be on a stable dose for at least 8 weeks prior to week 1.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.