Collection of Samples From Patients With MDS
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|ClinicalTrials.gov Identifier: NCT03072498|
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : March 26, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||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.|
|Actual Study Start Date :||April 6, 2017|
|Estimated Primary Completion Date :||December 5, 2020|
|Estimated Study Completion Date :||March 5, 2021|
- 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).
- Identification of patients' MDS-specific variant [ Time Frame: 2 years ]To select variants by comparing MDS versus non-MDS cell exome sequences. MDS-specific variant sequences are defined as those that differ between the two and are not common polymorphisms. We will also compare myeloid and lymphoid hematopoietic cells and assess the number of myeloid-specific vs myeloid and lymphoid MDS-related variants
- Immunogenic mutant neoantigen peptide selection [ Time Frame: 2 years ]To select putative mutation-driven neoantigen-related peptides, which represent the sequences obtained from Aim 2, according to their ability to bind to the patient's MHC using PersImmune's licensed and proprietary algorithms.
- Peptide Immunogenicity confirmation and donor T cell stimulation [ Time Frame: 2 years ]To test the neoantigen peptides for their in vitro immunogenicity for autologous T lymphocytes.
- Peptide immunogenicity confirmation and donor T cell stimulation [ Time Frame: 2 years ]To test the potency and specificity of neoantigen peptide-stimulated T cells for the patient's MDS cells that express the defined neoantigens.
- Data analysis and interpretation [ Time Frame: 2 years ]To create a database summarizing the data obtained.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072498
|Contact: Rafael Bejar, MDemail@example.com|
|Contact: Tiffany Tanaka, MDfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine||Recruiting|
|Irvine, California, United States, 92868|
|Contact: Chao Family Comprehensive Cancer Center 877-827-8839 email@example.com|
|Contact: Jessica Limson 7145096233 firstname.lastname@example.org|
|Principal Investigator: Deepa Jeyakumar, M.D.|
|University of California San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Colin McCarthy 858-534-8127 email@example.com|
|Contact: Kimberly Aguilar 858-534-5201 firstname.lastname@example.org|
|Principal Investigator: Rafael Bejar, M.D., Ph.D.|
|Sub-Investigator: Tiffany Tanaka, M.D.|
|Principal Investigator:||Rafael Bejar, MD||UCSD|