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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 32 and weeks 55 or 80

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 32 and weeks 55 or 80

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Dose Limiting Toxicity (DLT)

Secondary outcome measures

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

67%

Musculoskeletal and connective tissue disorders

57%

Nervous system disorders

50%

Metabolism and nutrition disorders

50%

Gastrointestinal disorders

50%

Skin and subcutaneous tissue disorders

47%

Investigations

43%

Blood and lymphatic system disorders

43%

Respiratory, thoracic and mediastinal disorders

33%

Injury, poisoning and procedural complications

27%

Vascular disorders

23%

Infections and infestations

20%

Psychiatric disorders

13%

Eye disorders

10%

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

10%

Ear and labyrinth disorders

Renal and urinary disorders

Surgical and medical procedures

Reproductive system and breast disorders

Cardiac disorders

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (CDX-301, CDX-1401, and Poly-ICLC)

Arm II (CDX-1401 and Poly-ICLC)

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

0 / 5Eligibility criteria met

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

Myelofibrosis Research Study Groups: CALR mutated

Myelofibrosis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the status of Poly ICLC's governmental authorization?

"As Poly ICLC is currently in its first phase of clinical testing, there are limited data confirming the efficacy and safety of this medication. For this reason, our team assigned it a score of 1 on our scale from 1 to 3."

Answered by AI

Are there any available slots remaining in this research trial?

"Contrary to what was previously thought, the clinicaltrials.gov listing for this medical trial confirms that it is no longer enrolling participants. This study began recruiting on July 1st 2022 and its latest edit occurred 6 days ago. Nevertheless, there are a plethora of other trials actively searching for candidates at the moment - 2513 in total!"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm

Marina Kremyanskaya 2023. "Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05025488.

All > Essential Thrombocythemia > Myelofibrosis