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Mutant CALR-peptide Based Vaccine for Myeloproliferative Neoplasms

This study is testing a new vaccine called Mutant-CALR peptides, along with another drug called Poly ICLC, for people with certain myeloproliferative neoplasms (MPNs) like myelofibrosis and essential thrombocythemia. These conditions are caused by a specific change (mutation) in the CALR gene. The vaccine aims to help your body's immune system (its defense against disease) recognize and fight off the cells with this mutation. Researchers want to see how safe the vaccine is and if people can tolerate it well. They plan to enroll 10 participants who are at least 18 years old and have a confirmed CALR mutation in their MPN. The main goal is to measure any serious side effects within 32 weeks.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved
You would receive ten doses of the Mutant-CALR peptides and ten doses of Poly ICLC over 31 weeks. You would also complete questionnaires, have bone marrow biopsies, and provide blood samples for research and standard lab tests. Your participation could last up to 80 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary safety measure will be assessed at 32 weeks.

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NCT05025488

Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm

Recruiting
PHASE1Ages 18+InterventionalTreatment
Marina Kremyanskaya
~10 participants
Updated 2025-04-06 on ClinicalTrials.gov
What's tested:Peptide-based vaccinePoly ICLC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose Limiting Toxicity (DLT)
Measured over 32 weeks

Conditions

Myelofibrosis
Essential Thrombocythemia
MPN

Explore related trials

Essential ThrombocythemiaMyelofibrosisMyeloproliferative NeoplasmCALR Gene

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Marina Kremyanskaya, MD, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Nina Bhardwaj, MD, PhD · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai
  • Camelia Iancu-Rubin, PhD · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai

Who to contact

Marina Kremyanskaya, MD, PhD
[email protected]
(212) 241-4106
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Dose Limiting Toxicity (DLT)32 weeks

    The Dose Limiting Toxicity (DLT) rate, defined as the proportion of patients with at least 1 grade 3 or higher AE considered to be at least possibly related to the treatment with Poly ICLC and CALR vaccines.