Samples From Leukemia Patients and Their Donors to Identify Specific Antigens

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02667093
• Other study ID #: Persimmune Sample Collection
• Status: Active, not recruiting
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: PersImmune, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
PersImmune, Inc	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

Kreiter S, Castle JC, Türeci O, Sahin U. Targeting the tumor mutanome for personalized vaccination therapy. Oncoimmunology. 2012 Aug 1;1(5):768-769. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomics of patients with leukemia and their HLA matched bone marrow transplant donors.	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.	5 years
Secondary	Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors	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.	5 years
Secondary	Immunogenic mutant neoantigen peptide selection	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.	5 years
Secondary	Peptide immunogenicity confirmation and donor T cell stimulation	To test the peptides from Aim 3 for their in vitro immunogenicity for T lymphocytes obtained from the donor.	5 years
Secondary	Data analysis and interpretation	To create and analyze a database summarizing the data obtained from Aims 1-4 for the purpose of IND submission and clinical trial design.	5 years