Samples From Leukemia Patients and Their Donors to Identify Specific Antigens

NCT ID: NCT02667093

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2020-12-31

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.

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• NA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

PersImmune, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Ball, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California San Diego

La Jolla, California, United States

Northside Hospital

Atlanta, Georgia, United States

Countries

United States

References

Montagna D, Maccario R, Locatelli F, Rosti V, Yang Y, Farness P, Moretta A, Comoli P, Montini E, Vitiello A. Ex vivo priming for long-term maintenance of antileukemia human cytotoxic T cells suggests a general procedure for adoptive immunotherapy. Blood. 2001 Dec 1;98(12):3359-66. doi: 10.1182/blood.v98.12.3359.

Reference Type: BACKGROUND

PMID: 11719375 (View on PubMed)

Kreiter S, Castle JC, Tureci O, Sahin U. Targeting the tumor mutanome for personalized vaccination therapy. Oncoimmunology. 2012 Aug 1;1(5):768-769. doi: 10.4161/onci.19727.

Reference Type: BACKGROUND

PMID: 22934277 (View on PubMed)

Klebanoff CA, Gattinoni L, Restifo NP. Sorting through subsets: which T-cell populations mediate highly effective adoptive immunotherapy? J Immunother. 2012 Nov-Dec;35(9):651-60. doi: 10.1097/CJI.0b013e31827806e6.

Reference Type: BACKGROUND

PMID: 23090074 (View on PubMed)

Brenner MK. Will T-cell therapy for cancer ever be a standard of care? Cancer Gene Ther. 2012 Dec;19(12):818-21. doi: 10.1038/cgt.2012.74. Epub 2012 Oct 12.

Reference Type: BACKGROUND

PMID: 23059871 (View on PubMed)

Other Identifiers

Persimmune Sample Collection

Identifier Type: -

Identifier Source: org_study_id