Last reviewed · How we verify
NCT03566446
CALR Exon 9 Mutant Peptide Vaccine to Patients With CALR-mutant Myeloproliferative Neoplasms
Phase 1 trial testing CALRLong36 peptide in Myeloproliferative Neoplasm, Unclassifiable in 10 participants. Completed in 30 April 2021.
20 February 2020
Quick facts
| Lead sponsor | Inge Marie Svane |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 20 June 2018 |
| Primary completion | 20 February 2020 |
| Estimated completion | 30 April 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- CALRLong36 peptide — full drug profile →
Conditions studied
- Myeloproliferative Neoplasm, Unclassifiable — all drugs for Myeloproliferative Neoplasm, Unclassifiable →
- Essential Thrombocythemia — all drugs for Essential Thrombocythemia →
- Myelofibrosis — all drugs for Myelofibrosis →
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):
-
Calreticulin and cancer.
Fucikova J, Spisek R, Kroemer G, Galluzzi L. · · 2021 · cited 322× · PMID 32733014 · DOI 10.1038/s41422-020-0383-9 -
Mutant calreticulin in myeloproliferative neoplasms.
How J, Hobbs GS, Mullally A. · · 2019 · cited 64× · PMID 31562135 · DOI 10.1182/blood.2019000622 -
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 -
Novel therapeutics in myeloproliferative neoplasms.
Venugopal S, Mascarenhas J. · · 2020 · cited 32× · PMID 33267911 · DOI 10.1186/s13045-020-00995-y -
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 -
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 -
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 -
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:
- PubMed search for NCT03566446
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myeloproliferative Neoplasm, Unclassifiable
Currently open trials in the same condition.
- NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel · recruiting
- NCT03862157 — Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Phase 1, PHASE2 · active not recruiting
Other Inge Marie Svane trials
Trials by the same sponsor.
- NCT07501117 — Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma · Phase 1 · not yet recruiting
- NCT06204991 — To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma · Phase 1 · recruiting
- NCT06783270 — T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma · Phase 1 · recruiting
- NCT04904185 — ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma · Phase 1 · terminated
- NCT04611126 — T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03566446 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Inge Marie Svane
- Last refreshed: 13 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03566446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing