CALR Exon 9 Mutant Peptide Vaccine to Patients With CALR-mutant Myeloproliferative Neoplasms
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|ClinicalTrials.gov Identifier: NCT03566446|
Recruitment Status : Unknown
Verified February 2019 by Inge Marie Svane, Herlev Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myeloproliferative Neoplasm, Unclassifiable Essential Thrombocythemia Myelofibrosis||Biological: CALRLong36 peptide||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase-1-first in Man Study in Patients With CALR-mutant Myeloproliferative Neoplasms by Vaccinating With CALR Exon 9 Mutant Peptide|
|Actual Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||February 20, 2020|
|Estimated Study Completion Date :||April 30, 2021|
Experimental: 36 aminoacid CALR exon 9 mutated peptide
15 vaccines, over the course of 1 year
Biological: CALRLong36 peptide
200 ug CALRLong36 peptide in water mixed with 500ul montanide
- Adverse events evaluated by CTCAE 4.03 [ Time Frame: 1 year ]Adverse events are graded 1-5 according to the criteria
- Immune responses [ Time Frame: 1 year ]T-cell cytokine release towards target antigens
- Mutational status [ Time Frame: 1 year ]CALR-mutational status
- Bone marrow response [ Time Frame: 1 year ]bone marrow description
- mutational landscape change [ Time Frame: 1 year ]Next Generation Sequencing pre- and post-treatment
- Overall response [ Time Frame: 1 year ]Revised response criteria by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus report
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566446
|Herlev, Capital Region, Denmark, 2730|
|Principal Investigator:||Jacob H Grauslund, MD||Center for Cancer Immune Therapy, Denmark|