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NCT03566446

CALR Exon 9 Mutant Peptide Vaccine to Patients With CALR-mutant Myeloproliferative Neoplasms

Completed Phase 1 Last updated 13 July 2023
What this trial tests

Phase 1 trial testing CALRLong36 peptide in Myeloproliferative Neoplasm, Unclassifiable in 10 participants. Completed in 30 April 2021.

Timeline
20 June 2018
Primary endpoint
20 February 2020
30 April 2021

Quick facts

Lead sponsorInge Marie Svane
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date20 June 2018
Primary completion20 February 2020
Estimated completion30 April 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Inge Marie Svane — full company profile →

Who can join

18 and older, any sex, with Myeloproliferative Neoplasm, Unclassifiable or Essential Thrombocythemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Calreticulin and cancer.
    Fucikova J, Spisek R, Kroemer G, Galluzzi L. · · 2021 · cited 322× · PMID 32733014 · DOI 10.1038/s41422-020-0383-9
  2. Mutant calreticulin in myeloproliferative neoplasms.
    How J, Hobbs GS, Mullally A. · · 2019 · cited 64× · PMID 31562135 · DOI 10.1182/blood.2019000622
  3. Therapeutic Cancer Vaccination With a Peptide Derived From the Calreticulin Exon 9 Mutations Induces Strong Cellular Immune Responses in Patients With <i>CALR</i>-Mutant Chronic Myeloproliferative Neoplasms.
    Handlos Grauslund J, Holmström MO, Jørgensen NG, Klausen U, et al · · 2021 · cited 38× · PMID 33718228 · DOI 10.3389/fonc.2021.637420
  4. Novel therapeutics in myeloproliferative neoplasms.
    Venugopal S, Mascarenhas J. · · 2020 · cited 32× · PMID 33267911 · DOI 10.1186/s13045-020-00995-y
  5. High frequencies of circulating memory T cells specific for calreticulin exon 9 mutations in healthy individuals.
    Holmström MO, Ahmad SM, Klausen U, Bendtsen SK, et al · · 2019 · cited 30× · PMID 30655510 · DOI 10.1038/s41408-018-0166-4
  6. Inflammatory Microenvironment and Specific T Cells in Myeloproliferative Neoplasms: Immunopathogenesis and Novel Immunotherapies.
    Nasillo V, Riva G, Paolini A, Forghieri F, et al · · 2021 · cited 28× · PMID 33672997 · DOI 10.3390/ijms22041906
  7. Cancer Immune Therapy for Philadelphia Chromosome-Negative Chronic Myeloproliferative Neoplasms.
    Holmström MO, Hasselbalch HC, Andersen MH. · · 2020 · cited 22× · PMID 32630667 · DOI 10.3390/cancers12071763
  8. PD-1/PD-L1, MDSC Pathways, and Checkpoint Inhibitor Therapy in <i>Ph</i>(-) Myeloproliferative Neoplasm: A Review.
    Wang JC, Sun L. · · 2022 · cited 18× · PMID 35628647 · DOI 10.3390/ijms23105837

Verify or expand the search:

Other recruiting trials for Myeloproliferative Neoplasm, Unclassifiable

Currently open trials in the same condition.

Other Inge Marie Svane trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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