- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02667093
Samples From Leukemia Patients and Their Donors to Identify Specific Antigens
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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La Jolla, California, Forenede Stater, 92093
- University of California San Diego
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Northside Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Diagnosis of AML with plan to receive a bone marrow transplant
Exclusion Criteria:
- NA
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Genomics of patients with leukemia and their HLA matched bone marrow transplant donors.
Tidsramme: 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.
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5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors
Tidsramme: 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.
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5 years
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Immunogenic mutant neoantigen peptide selection
Tidsramme: 5 years
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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.
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5 years
|
Peptide immunogenicity confirmation and donor T cell stimulation
Tidsramme: 5 years
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To test the peptides from Aim 3 for their in vitro immunogenicity for T lymphocytes obtained from the donor.
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5 years
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Data analysis and interpretation
Tidsramme: 5 years
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To create and analyze a database summarizing the data obtained from Aims 1-4 for the purpose of IND submission and clinical trial design.
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5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edward Ball, MD, University of California, San Diego
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Persimmune Sample Collection
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Akut myeloid leukæmi
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University of PennsylvaniaAktiv, ikke rekrutterendeAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi, refraktær | Akut myeloid leukæmi, pædiatriskForenede Stater
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Washington University School of MedicineTrukket tilbageRefraktær akut myeloid leukæmi | Recidiverende akut myeloid leukæmiForenede Stater
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C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.AfsluttetAkut myeloid leukæmi | Refraktær akut myeloid leukæmi | Recidiverende akut myeloid leukæmiForenede Stater
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Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetAkut myeloid leukæmi i barndommen/andre myeloid malignitetForenede Stater
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Ascentage Pharma Group Inc.Suzhou Yasheng Pharmaceutical Co., Ltd.RekrutteringMyeloid malignitet | Recidiverende/Refraktær Akut Myeloid LeukæmiKina
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Peking University People's HospitalBeijing JD Biotech Co. LTD.RekrutteringAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktærKina
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Xuzhou Medical UniversityRekrutteringAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktærKina
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Bio-Path Holdings, Inc.RekrutteringAkut myeloid leukæmi, i tilbagefald | Akut myeloid leukæmi refraktærForenede Stater
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Yale UniversityPfizerAfsluttetAKUT MYELOID LEUKÆMIForenede Stater
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University of WashingtonAfsluttetTilbagevendende akut myeloid leukæmi | Refraktær akut myeloid leukæmi | Myeloid neoplasmaForenede Stater