IND-Enabling Studies for a Clinical Trial to Genetically Program a Persistent Cancer-Targeted Immune System.
Animals
Antigens, Neoplasm
/ genetics
Cells, Cultured
Clinical Trials as Topic
Drugs, Investigational
/ therapeutic use
Genetic Therapy
/ methods
HLA-A2 Antigen
/ genetics
Hematopoietic Stem Cells
/ immunology
Humans
Immunotherapy, Adoptive
/ methods
Membrane Proteins
/ genetics
Mice, Inbred C57BL
Mice, Transgenic
Neoplasms
/ genetics
Receptors, Antigen, T-Cell
/ genetics
T-Lymphocytes
/ immunology
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
01 02 2019
01 02 2019
Historique:
received:
27
03
2018
revised:
21
06
2018
accepted:
05
11
2018
pubmed:
10
11
2018
medline:
14
4
2020
entrez:
10
11
2018
Statut:
ppublish
Résumé
To improve persistence of adoptively transferred T-cell receptor (TCR)-engineered T cells and durable clinical responses, we designed a clinical trial to transplant genetically-modified hematopoietic stem cells (HSCs) together with adoptive cell transfer of T cells both engineered to express an NY-ESO-1 TCR. Here, we report the preclinical studies performed to enable an investigational new drug (IND) application. HSCs transduced with a lentiviral vector expressing NY-ESO-1 TCR and the PET reporter/suicide gene HSV1-sr39TK and T cells transduced with a retroviral vector expressing NY-ESO-1 TCR were coadministered to myelodepleted HLA-A2/K TCR genetically modified and Coadministration of HSCs and T cells expressing an NY-ESO-1 TCR is safe in preclinical models. The results presented in this article led to the FDA approval of IND 17471.
Identifiants
pubmed: 30409823
pii: 1078-0432.CCR-18-0963
doi: 10.1158/1078-0432.CCR-18-0963
pmc: PMC6359988
mid: NIHMS1512381
doi:
Substances chimiques
Antigens, Neoplasm
0
CTAG1B protein, human
0
Drugs, Investigational
0
HLA-A2 Antigen
0
Membrane Proteins
0
Receptors, Antigen, T-Cell
0
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
1000-1011Subventions
Organisme : NCI NIH HHS
ID : R35 CA197633
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA016042
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI028697
Pays : United States
Organisme : NHLBI NIH HHS
ID : P40 HL116242
Pays : United States
Organisme : NCI NIH HHS
ID : P01 CA168585
Pays : United States
Informations de copyright
©2018 American Association for Cancer Research.
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