Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarina Kremyanskaya
About this trial
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
Qualifiers
Subjects must be ≥18 years of age at the time of signing the informed consent form.
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Peptide-based vaccine
- Poly ICLC
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Marina Kremyanskaya
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov