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Clinical Trials/NCT03072498
NCT03072498
Unknown
Not Applicable

Collection of Bone Marrow, Peripheral Blood (PB), Epithelial Tissue, and Saliva Samples From Patients With Myelodysplastic Syndromes (MDS) to Identify MDS-Specific Antigens (MSA) for Use in Cellular Immunotherapy.

PersImmune, Inc2 sites in 1 country24 target enrollmentApril 6, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myelodysplastic Syndromes(MDS)
Sponsor
PersImmune, Inc
Enrollment
24
Locations
2
Primary Endpoint
Genomics of patients with MDS
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating MDS.

Detailed Description

Goals of the study: The purpose of this study is to collect the blood and marrow samples, and non-involved fibroblasts, that are required to identify the unique, personalized array of mutation-driven neoantigens that are expressed by the subject's MDS cells and to assess the feasibility of immunizing and expanding one or more of the patient's T cells ex vivo for investigation of their use as adoptive cellular immunotherapy.

Registry
clinicaltrials.gov
Start Date
April 6, 2017
End Date
March 5, 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Genomics of patients with MDS

Time Frame: 2 years

To sequence the exome and transcriptome obtained from MDS hematopoietic cells and the exome from non-hematopoietic cells (e.g. fibroblasts).

Secondary Outcomes

  • Identification of patients' MDS-specific variant(2 years)
  • Immunogenic mutant neoantigen peptide selection(2 years)
  • Data analysis and interpretation(2 years)
  • Peptide Immunogenicity confirmation and donor T cell stimulation(2 years)
  • Peptide immunogenicity confirmation and donor T cell stimulation(2 years)

Study Sites (2)

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