Trials / Completed
CompletedNCT03566446
CALR Exon 9 Mutant Peptide Vaccine to Patients With CALR-mutant Myeloproliferative Neoplasms
A Phase-1-first in Man Study in Patients With CALR-mutant Myeloproliferative Neoplasms by Vaccinating With CALR Exon 9 Mutant Peptide
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Inge Marie Svane · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase-I-first in man study in patients with calreticulin(CALR)-mutant MPN by vaccinating with exon 9 mutated peptide with the adjuvant Montanide ISA-51 to monitor safety and toxicity and the immunological response to vaccination.
Detailed description
The Philadelphia-chromosome negative chronic myeloproliferative neoplasms (MPN) are acquired cancer diseases, that arise due to mutations in the hematopoietic stem cells in the bone marrow. Median age at diagnosis is approximately 65 years of age and approximately 400 Danes are diagnosed with MPN annually. The MPN comprise essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (PMF). In December 2013 two independent research groups reported on the occurrence of somatic mutations in exon 9 of the calreticulin gene in patients with ET and PMF. The overall rationale for a vaccine with CALR-mutant epitopes is that it will initiate a CALR-mutant specific immune response, which will "release the brakes" on the CALR-mutant specific immune response. 10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CALRLong36 peptide | 200 ug CALRLong36 peptide in water mixed with 500ul montanide |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2020-02-20
- Completion
- 2021-04-30
- First posted
- 2018-06-25
- Last updated
- 2023-07-13
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03566446. Inclusion in this directory is not an endorsement.