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

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05444530
Phase
PHASE1
Status
Completed

Conditions

  • Myeloproliferative Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VAC85135 — BIOLOGICAL
    Participants will receive VAC85135 as IM injection.
  • Ipilimumab — DRUG
    Participants will receive Ipilimumab as IV infusion.

Study Details

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

Key Dates

Start date
Jul 21, 2022
Status verified
Jul 2025
Primary completion
Jun 24, 2025
Completion
Jun 24, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants 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.
  • Experimental: Dose Expansion
    Participants 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).

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicity (DLT) [ Time Frame: Baseline (Day 1) up to Day 78 ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Moffitt Cancer CenterTampaFlorida33612-
Cleveland ClinicClevelandOhio44195-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAMoffitt Cancer Center· Tampa, FLCleveland Clinic· Cleveland, OHMD Anderson Cancer Center· Houston, TX

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