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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
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
PersImmune, Inc

Brief Summary:
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.

Condition or disease
Acute Myeloid Leukemia

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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
Samples will be shipped to Persimmune for processing and storage with results shared with Dr. Ball and his lab at UCSD.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with leukemia and their potential bone marrow donors.
Criteria

Inclusion Criteria:

  • Diagnosis of AML with plan to receive a bone marrow transplant

Exclusion Criteria:


Information from the National Library of Medicine

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


Contacts
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Contact: Thomas Lane, MD 858-704-4499 tlane@persimmune.com

Locations
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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
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Asad Bashey, MD    404-255-1930    abashey@bmtga.com   
Contact: Stacey Brown    404-851-8238    stacey.brown@northside.com   
Sponsors and Collaborators
PersImmune, Inc
University of California, San Diego
Investigators
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Principal Investigator: Edward Ball, MD University of California, San Diego

Publications:
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Responsible Party: PersImmune, Inc
ClinicalTrials.gov Identifier: NCT02667093     History of Changes
Other Study ID Numbers: Persimmune Sample Collection
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by PersImmune, Inc:
Acute Leukemia
Acute Myeloid Leukemia
AML

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms