NCT05025488 is a Phase 1 clinical trial of Peptide-based vaccine in Myelofibrosis, sponsored by Marina Kremyanskaya.

Who is sponsoring NCT05025488?

NCT05025488 is sponsored by Marina Kremyanskaya.

What drugs are being tested in NCT05025488?

Interventions in NCT05025488: Peptide-based vaccine, Poly ICLC.

What condition does NCT05025488 study?

NCT05025488 studies Myelofibrosis, Essential Thrombocythemia, MPN.

Is NCT05025488 still recruiting?

NCT05025488 is currently recruiting now. Last updated 3 April 2025.

Last reviewed 2025-04-03 · How we verify

NCT05025488

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I Open Label Peptide Based Vaccine in Patients With Myeloproliferative Neoplasm Harboring CALR Mutations

Recruiting now Phase 1 Last updated 3 April 2025

What this trial tests

Phase 1 trial testing Peptide-based vaccine in Myelofibrosis in 10 participants. Currently enrolling.

Timeline

4 April 2023

Primary endpoint
1 March 2027

1 March 2027

Quick facts

Lead sponsor	Marina Kremyanskaya
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	4 April 2023
Primary completion	1 March 2027
Estimated completion	1 March 2027
Sites	1 location across United States

Drugs / interventions tested

Peptide-based vaccine — full drug profile →
Poly ICLC — full drug profile →

Conditions studied

Myelofibrosis — all drugs for Myelofibrosis →
Essential Thrombocythemia — all drugs for Essential Thrombocythemia →
MPN — all drugs for MPN →

Sponsor

Marina Kremyanskaya — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants with Dose Limiting Toxicity (DLT)
Time frame: 32 weeks
The Dose Limiting Toxicity (DLT) rate, defined as the proportion of patients with at least 1 grade 3 or higher AE considered to be at least possibly related to the treatment with Poly ICLC and CALR vaccines.

Sponsor's own description

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.

Publications & conference data

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

Myelofibrosis.
Passamonti F, Mora B. · · 2023 · cited 82× · PMID 36416738 · DOI 10.1182/blood.2022017423
Recent Findings on Therapeutic Cancer Vaccines: An Updated Review.
Sheikhlary S, Lopez DH, Moghimi S, Sun B. · · 2024 · cited 8× · PMID 38672519 · DOI 10.3390/biom14040503
Targeted Therapies in Myelofibrosis: Present Landscape, Ongoing Studies, and Future Perspectives.
Loscocco GG, Guglielmelli P. · · 2025 · cited 7× · PMID 40062529 · DOI 10.1002/ajh.27658
Novel approaches in myelofibrosis.
Koschmieder S. · · 2024 · cited 7× · PMID 39670187 · DOI 10.1002/hem3.70056
Antibody targeting of mutant calreticulin in myeloproliferative neoplasms.
Kramer F, Mullally A. · · 2024 · cited 7× · PMID 37551061 · DOI 10.1111/jcmm.17896
Multi-disciplinary approaches paving the way for clinically effective peptide vaccines for cancer.
Shah BA, Holden JA, Lenzo JC, Hadjigol S, et al · · 2025 · cited 6× · PMID 40204832 · DOI 10.1038/s41541-025-01118-9
Mutant Calreticulin in MPN: Mechanistic Insights and Therapeutic Implications.
Faiz M, Riedemann M, Jutzi JS, Mullally A. · · 2025 · cited 2× · PMID 39775969 · DOI 10.1007/s11899-024-00749-4
Evolution of myeloproliferative neoplasms from normal blood stem cells.
Hormoz S, Sankaran VG, Mullally A. · · 2025 · cited 2× · PMID 39633553 · DOI 10.3324/haematol.2023.283951

Verify or expand the search:

Other recruiting trials for Myelofibrosis

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06781099 — Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis · NA · recruiting
NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel · recruiting
NCT07342712 — Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels · active not recruiting
NCT06533813 — Clinical Epidemiology in Contemporary Patients With Myelofibrosis. · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05025488 (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 Marina Kremyanskaya
Last refreshed: 3 April 2025

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/NCT05025488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing