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Cancer Vaccine

Peptide-based Vaccine for Myeloproliferative Disorders

Phase 1
Recruiting
Led By Michal Bar-Natan, MD
Research Sponsored by Michal Bar-Natan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of chronic phase MPN: high risk ET (HU failure/intolerance), low-intermediate 1 (DIPSS 0-1) PMF
Subjects must be ≥18 years of age at the time of signing the informed consent form
Must not have
Current Ruxolitinib or Fedratinib use
Current use of hydroxyurea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 32 and weeks 55 or 80
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new vaccine for patients with bone marrow disorders. Up to 10 patients will be enrolled over 12 months, with a maximum participation of 80 weeks. They will complete questionnaires and have bone marrow biopsies and standard of care lab tests.

Who is the study for?
This trial is for adults over 18 with certain types of myeloproliferative neoplasms (MPNs) who have a specific CALR mutation. Participants need normal organ function, no recent other cancers except some localized ones, and can't be on certain medications or have serious infections or autoimmune diseases. They must use effective birth control if applicable.
What is being tested?
The study tests the safety of a mutated-CALR peptide vaccine in MPN patients at The Mount Sinai Hospital. Over 80 weeks, participants will receive the vaccine along with Poly ICLC adjuvant, complete questionnaires, undergo bone marrow biopsies and lab collections.
What are the potential side effects?
Potential side effects may include typical reactions to vaccines such as soreness at injection site, fever, fatigue or allergic responses. Since this is an investigational treatment, there may be unknown risks that will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed chronic MPN and am considered high risk or low-intermediate risk.
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I am 18 years old or older.
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My tests show a CALR exon 9 mutation.
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I can do most of my daily activities by myself.
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My white blood cell count is healthy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking Ruxolitinib or Fedratinib.
Select...
I am currently taking hydroxyurea.
Select...
I am not willing to use birth control.
Select...
I am currently taking medications that suppress my immune system.
Select...
I do not have any serious infections that are not under control.
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I am not currently using INF, but I may be taking anagrelide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 32 and weeks 55 or 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 32 and weeks 55 or 80 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Dose Limiting Toxicity (DLT)
Secondary study objectives
Change in CALR VAF
Change in Immune Milieu Composite
Myelofibrosis Symptom Assessment Form (MF-SAFv4.0)
+4 more

Side effects data

From 2018 Phase 2 trial • 60 Patients • NCT02129075
100%
General disorders and administration site conditions
63%
Nervous system disorders
60%
Musculoskeletal and connective tissue disorders
57%
Gastrointestinal disorders
47%
Investigations
47%
Skin and subcutaneous tissue disorders
43%
Respiratory, thoracic and mediastinal disorders
40%
Metabolism and nutrition disorders
33%
Blood and lymphatic system disorders
30%
Infections and infestations
20%
Vascular disorders
13%
Psychiatric disorders
10%
Eye disorders
10%
Renal and urinary disorders
10%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
7%
Cardiac disorders
7%
Surgical and medical procedures
7%
Reproductive system and breast disorders
3%
Immune system disorders
3%
Pregnancy, puerperium and perinatal conditions
3%
Injury, poisoning and procedural complications
3%
Ear and labyrinth disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (CDX-1401 and Poly-ICLC)
Arm I (CDX-301, CDX-1401, and Poly-ICLC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CALR mutatedExperimental Treatment2 Interventions
peptide-based vaccine in patients with myeloproliferative neoplasm (myelofibrosis and essential thrombocythemia) with CALR mutations
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Poly ICLC
2014
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Michal Bar-NatanLead Sponsor
Marina KremyanskayaLead Sponsor
1 Previous Clinical Trials
Michal Bar-Natan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Mutant CALR-peptide Based Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05025488 — Phase 1
Essential Thrombocythemia Research Study Groups: CALR mutated
Essential Thrombocythemia Clinical Trial 2023: Mutant CALR-peptide Based Vaccine Highlights & Side Effects. Trial Name: NCT05025488 — Phase 1
Mutant CALR-peptide Based Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025488 — Phase 1
~4 spots leftby Mar 2026
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