Samples From Leukemia Patients and Their Donors to Identify Specific Antigens
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|ClinicalTrials.gov Identifier: NCT02667093|
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : April 4, 2018
|Condition or disease|
|Acute Myeloid Leukemia|
It is well known that tumor cells and leukemia cells express different surface structures (called antigens) that can serve as targets for cancer cell destruction by the immune system. Effective immune therapies are characterized by high specificity and low toxicity. One of the major obstacles impeding the use of these therapies as standard of care is the identification of good target antigens. In acute myeloid leukemia (AML) there is major patient to patient variation in leukemia antigens, so there is no universal AML cell target. Rather, each patient has a unique array of potential cell targets. Thanks to the rapid progress of new DNA/RNA sequencing technologies, the identification of these unique, patient-specific leukemia cell antigen-targets is now possible.
The purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Bone Marrow and Peripheral Blood (PB) Samples From Patients With Leukemia and PB From Their BM Donors (BMD) to Identify Leukemia-Specific Antigens (LSA) and Graft Versus Host Disease Antigens (GVHDA) for Use in Cellular Immunotherapy|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
- Genomics of patients with leukemia and their HLA matched bone marrow transplant donors. [ Time Frame: 5 years ]To sequence the exome and transcriptome obtained from leukemia cells and the exome from their lymphocytes, and the lymphocytes from their HLA matched marrow transplant donors.
- Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors [ Time Frame: 5 years ]To select leukemia specific mutations (aka, variants), ie those that are different from both the patient's non-leukemic cells and their HLA matched marrow transplant donor's immune cells by comparing Leukemia cell, Patient normal cell, and Donor exome sequences.
- Immunogenic mutant neoantigen peptide selection [ Time Frame: 5 years ]To select peptides that represent the sequences obtained from Aim 2, according to their ability to bind to the identical patient/donor T cell major histocompatibility receptors.
- Peptide immunogenicity confirmation and donor T cell stimulation [ Time Frame: 5 years ]To test the peptides from Aim 3 for their in vitro immunogenicity for T lymphocytes obtained from the donor.
- Data analysis and interpretation [ Time Frame: 5 years ]To create and analyze a database summarizing the data obtained from Aims 1-4 for the purpose of IND submission and clinical trial design.
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): NCT02667093
|Contact: Thomas Lane, MDemail@example.com|
|United States, California|
|University of California San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Jesika Reiner, MPH 858-822-5364 JReiner@ucsd.edu|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|Contact: Asad Bashey, MD 404-255-1930 firstname.lastname@example.org|
|Contact: Stacey Brown 404-851-8238 email@example.com|
|Principal Investigator:||Edward Ball, MD||University of California, San Diego|