First-in-human phase I clinical trial of the NY-ESO-1 protein cancer vaccine with NOD2 and TLR9 stimulants in patients with NY-ESO-1-expressing refractory solid tumors.
Adult
Aged
Aged, 80 and over
Animals
Antibodies, Neoplasm
/ blood
Antigens, Neoplasm
/ immunology
CD8-Positive T-Lymphocytes
/ drug effects
Cancer Vaccines
/ administration & dosage
Cell Line, Tumor
Female
Humans
Interferon-gamma
/ immunology
Male
Membrane Proteins
/ immunology
Mice, Inbred BALB C
Middle Aged
Neoplasms
/ immunology
Nod2 Signaling Adaptor Protein
/ immunology
Toll-Like Receptor 9
/ immunology
Vaccination
/ methods
Cancer vaccine
NOD2
NY-ESO-1 antigen
TLR9
Journal
Cancer immunology, immunotherapy : CII
ISSN: 1432-0851
Titre abrégé: Cancer Immunol Immunother
Pays: Germany
ID NLM: 8605732
Informations de publication
Date de publication:
Apr 2020
Apr 2020
Historique:
received:
22
03
2019
accepted:
04
01
2020
pubmed:
26
1
2020
medline:
21
4
2020
entrez:
26
1
2020
Statut:
ppublish
Résumé
Cholesteryl pullulan (CHP) is a novel antigen delivery system. CHP and New York esophageal squamous cell carcinoma 1 (NY-ESO-1) antigen complexes (CHP-NY-ESO-1) present multiple epitope peptides to the MHC class I and II pathways. Adjuvants are essential for cancer vaccines. MIS416 is a non-toxic microparticle that activates immunity via the nucleotide-binding oligomerization domain 2 (NOD2) and TLR9 pathways. However, no reports have explored MIS416 as a cancer vaccine adjuvant. We conducted a first-in-human clinical trial of CHP-NY-ESO-1 with MIS416 in patients with NY-ESO-1-expressing refractory solid tumors. CHP-NY-ESO-1/MIS416 (μg/μg) was administered at 100/200, 200/200, 200/400 or 200/600 (cohorts 1, 2, 3 and 4, respectively) every 2 weeks for a total of 6 doses (treatment phase) followed by one vaccination every 4 weeks until disease progression or unacceptable toxicity (maintenance phase). The primary endpoints were safety and tolerability, and the secondary endpoint was the immune response. In total, 26 patients were enrolled. Seven patients (38%) continued vaccination in the maintenance phase. Grade 3 drug-related adverse events (AEs) were observed in six patients (23%): anorexia and hypertension were observed in one and five patients, respectively. No grade 4-5 drug-related AEs were observed. Eight patients (31%) had stable disease (SD). Neither augmentation of the NY-ESO-1-specific IFN-γ-secreting CD8
Identifiants
pubmed: 31980914
doi: 10.1007/s00262-020-02483-1
pii: 10.1007/s00262-020-02483-1
pmc: PMC7113205
doi:
Substances chimiques
Antibodies, Neoplasm
0
Antigens, Neoplasm
0
CTAG1B protein, human
0
Cancer Vaccines
0
MIS416 vaccine
0
Membrane Proteins
0
NOD2 protein, human
0
Nod2 Signaling Adaptor Protein
0
Toll-Like Receptor 9
0
Interferon-gamma
82115-62-6
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
663-675Références
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