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NCT05444530CompletedPhase 1

A Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms

A Phase 1 Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered With Ipilimumab for the Treatment of Myeloproliferative Neoplasms

Source: ClinicalTrials.gov · Last updated 20 Jul 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety of VAC85135 administered with ipilimumab for the treatment of myeloproliferative neoplasms (MPNs).

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
14 (actual)
First submitted
30 Jun 2022
Start date
21 Jul 2022
Primary completion date
24 Jun 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05444530
EU CT number
2022-501913-30-00
EudraCT number
2021-006033-20

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 14
  • From 21 Jul 2022 to the primary completion date, 24 Jun 2025
  • 7 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with any Janus kinase 1/2 (JAK1/2) inhibitor

Other illness

  • History of any significant medical condition per investigators judgment (example: severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heart condition, insulin dependent diabetes mellitus)
  • Serious known clinically relevant allergies or earlier anaphylactic reactions

Other

  • Currently pregnant or breastfeeding
  • Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information

Who the study is looking for

  • Be positive for a CALR (calreticulin) mutation: Type 1 or Type 2; Type 1-like, or Type 2-like may be considered with Sponsor approval; or positive for the JAK2V617F (Janus kinase 2 with valine 617 to phenylalanine mutation) mutation with HLA-A02:01 (human leukocyte antigens) per medical history or local testing
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2
  • Have the following hematologic laboratory values: Leukocytes greater than or equal to (\>=) 1.5\*10\^9 per liter, Neutrophils \>=1.0\*10\^9 per liter, Platelets \>=20\*10\^9 per liter, Hemoglobin greater than (\>) 7 gram per deciliter (g/dL)
  • Have the following chemistry laboratory values: Alanine aminotransferase (ALT): less than or equal to (\<=) 3\*upper limit of normal (ULN), Aspartate aminotransferase (AST): \<=3\*ULN, Total bilirubin: \<=1.5\*ULN, and glomerular filtration rate \>=40 milliliter per minute (mL/min)
  • A female participant of childbearing potential must agree to all the following during the study and for 6 months after the last dose of study treatment: use a barrier method of contraception, use a highly effective preferably user-independent method of contraception, not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction, not plan to become pregnant, not to breast-feed
  • A male participant must agree to all the following during the study and for 90 days after the last dose of study treatment: wear a condom when engaging in any activity that allows for passage of ejaculate to another person, not to father a child, not to donate sperm or freeze for future use for the purpose of reproduction

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Guy's and St Thomas' Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust - Christie Hospital
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Churchill Hospital
Coordinator of this site? Confirm its status
OxfordUnited KingdomUnknown status
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
City of Hope
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Moffitt Cancer Center
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.