Acute Myeloid LeukemiaNCT02667093
Samples From Leukemia Patients and Their Donors to Identify Specific Antigens
An observational study of Acute Myeloid Leukemia, run by PersImmune, Inc at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with leukemia and their potential bone marrow donors.
Who may be able to join
- Diagnosis of AML with plan to receive a bone marrow transplant
Who cannot join
- NA
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northside Hospital
Atlanta, Georgia, 30342
University of California San Diego
La Jolla, California, 92093
About this study
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
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.
Read the 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
- Keywords
- Acute Leukemia, Acute Myeloid Leukemia, AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (4)
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- PersImmune, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Edward Ball, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667093
- Sponsor's protocol ID
- Persimmune Sample Collection
- Status last verified
- Mar 2020
- First submitted
- 25 Jan 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 11719375Kreiter 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.
PubMed 22934277Klebanoff 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.
PubMed 23090074Brenner 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.
PubMed 23059871
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02667093
- Acronym / sponsor ID
- Persimmune Sample Collection
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Leukemia, Acute Myeloid Leukemia, AML
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PersImmune, IncIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Diego
- Study start
- Jan 2013
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with leukemia and their potential bone marrow donors.
Key inclusion criteria (1 listed)
- Diagnosis of AML with plan to receive a bone marrow transplant
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors
Time frame: 5 years
Immunogenic mutant neoantigen peptide selection
Time frame: 5 years
Peptide immunogenicity confirmation and donor T cell stimulation
Time frame: 5 years
Data analysis and interpretation
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Background: PubMed 11719375Montagna 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.
- Background: PubMed 22934277Kreiter 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.
- Background: PubMed 23090074Klebanoff 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.
- Background: PubMed 23059871Brenner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Ball, MD principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by PersImmune, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomics of patients with leukemia and their HLA matched bone marrow transplant donors. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667093, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.