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Myeloproliferative NeoplasmsPhase 1NCT05444530

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

A Phase 1 study testing VAC85135 and Ipilimumab in people with Myeloproliferative Neoplasms, run by Janssen Research & Development, LLC at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloproliferative Neoplasms
What is being tested?
VAC85135 and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
7 sitesin 2 countries
Study dates
21 Jul 2022to 24 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • Currently pregnant or breastfeeding
  • Prior treatment with any Janus kinase 1/2 (JAK1/2) inhibitor
  • Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States4 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

United Kingdom3 sites

  • Guy's and St Thomas' Hospital

    London, SE1 9RT

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

  • Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

About this study

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

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

Being tested
VAC85135, Ipilimumab
Medical subject headings
Myeloproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VAC85135Biological

    Participants will receive VAC85135 as IM injection.

  • IpilimumabDrug

    Participants will receive Ipilimumab as IV infusion.

Study groups in NCT05444530
Study groupRoleWhat they receive
Dose EscalationExperimentalParticipants with essential thrombocythemia (ET) and myelofibrosis (MF) will receive VAC85135 target dose intramuscular (IM) injection in the safety lead-in cohort (Cohort 0). Participants in subsequent cohorts will receive VAC85135 target dose IM injection along with ipilimumab intravenous (IV) infusion. Ipilimumab dose may be escalated based on dose limiting toxicity (DLT) observations.
Receives: Biological: VAC85135; Drug: Ipilimumab
Dose ExpansionExperimentalParticipants with polycythemia vera (PV) or post-polycythemia vera myelofibrosis, ET and MF will receive VAC85135 target dose IM injection with ipilimumab IV infusion at the dose(s) determined by study evaluation team (SET).
Receives: Biological: VAC85135; Drug: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-limiting Toxicity (DLT)

    Number of participants with a DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. Toxicities will be graded for severity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

    Measured: Baseline (Day 1) up to Day 78

  2. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. AEs will be graded as Grade 1: Mild- asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate- minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4- Life-threatening consequences- urgent intervention indicated; Grade 5: Death related to AE.

    Measured: Up to 79 weeks

Secondary outcomes (8)

  1. Number of Participants With Antigen-specific T-cell response

    Number of participants with antigen-specific T-cell response will be reported.

    Measured: Up to end of treatment (EOT) (Up to 64 weeks)

  2. Number of Participants With Overall Response per Revised Response Criteria by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) Consensus Report

    Overall response will be measured by complete remission, partial remission, clinical improvement, anemia response, spleen response, symptoms response, progressive disease, stable disease and relapse as per the revised IWG-MRT and ELN response criteria for myelofibrosis (MF).

    Measured: Up to 79 weeks

  3. Number of Participants Disease Response at Weeks 24, 48 and End of Treatment (EOT) per Modified IWG-MRT Criteria

    Number of participants with disease response as per the modified IWG-MRT criteria will be reported.

    Measured: Weeks 24, 48 and EOT (64 weeks)

  4. Number of Participants With Peripheral Blood Mutant Calreticulin (mutCALR) and Janus Kinase 2 With V617F Mutation (JAK2V617F) Allele Burden

    Number of participants with peripheral blood mutCALR and JAK2V617F allele burden will be reported.

    Measured: Up to end of treatment (EOT) (Up to 64 weeks)

  5. Number of Participants With Transfusion Burden

    Number of participants with transfusion burden will be reported.

    Measured: Up to end of treatment (EOT) (Up to 64 weeks)

  6. Number of Participants With Patient-reported Symptoms on Therapy

    Number of participants with patient-reported symptoms on therapy will be reported.

    Measured: Up to end of treatment (EOT) (Up to 64 weeks)

  7. Time to Progression of Myeloproliferative Neoplasms (MPNs)

    Time to progression of MPNs (polycythemiavera [PV], essential thrombocythemia [ET], and primary myelofibrosis [PMF]) will be reported.

    Measured: Up to end of treatment (EOT) (Up to 64 weeks)

  8. Time to Initiation of Next Therapy

    Time to initiation of next therapy for myeloproliferative neoplasms (MPNs) will be reported.

    Measured: Up to 79 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start21 Jul 2022
  3. Primary completion24 Jun 2025
  4. Study completion24 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444530
Sponsor's protocol ID
CR109149
Other IDs
VAC85135MPN1001, 2021-006033-20, 2022-501913-30-00
Status last verified
Jul 2025
First submitted
30 Jun 2022
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VAC85135 and Ipilimumab in people with Myeloproliferative Neoplasms, run by Janssen Research & Development, LLC at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-limiting Toxicity (DLT) (time frame: Baseline (Day 1) up to Day 78). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.

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