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. 2024 Aug 31;12:93. doi: 10.1186/s40364-024-00644-3

Table 4.

Clinical trials of neoantigen mRNA vaccines

Cancer type NCT number Drug administration Phase Neoantigen Status Delivery system Result
Respiratory system tumors (mainly non-small cell lung cancer) non-small cell lung cancer NCT03908671 Personalized mRNA vaccine encoding neoantigen I Individual tumour mutations Not yet recruiting LPP(liposubcutaneousplex)nanodelivery Not published
NCT03948763 mRNA-5671 (KRAS gene driver mutations) + pembrolizumab I KRAS gene driver mutations Recruiting Lipid nanoparticles Not published
Skin tumor (mainly melanoma) melanoma NCT03897881 mRNA-4157 (personalised cancer vaccine encoding 20 different mutated neoepitopes) + With pembrolizumab II 20 different mutated neoepitopes Active,not recruiting Lipid nanoparticles Not published
NCT03480152 (NCI)-4650, a mRNA-based, personalized cancer vaccine I Immunogenic T-cell epitopes derived from neoantigens Terminated Naked mRNA Mutation-specific CD4 + and CD8 + T-cell responses against predicted neoepitopes in three (75%) of four patients.No objective clinical responses [24, 26]
NCT02035956 An individualised tumour mutation signature with ten selected neoepitopes for each patient I Ten selected neoepitopes for each patient Completed Naked mRNA Out of 125 selected new epitopes, 60% can stimulate T cell responses; Good tolerance to vaccination
NCT03480152 NCI-4650 I/II Immunogenic neoantigens Active, not recruiting LNP safe with a slight adverse event
NCT03468244 personalized mRNA tumor vaccine NA Individual tumour mutations Recruiting LPP Not published
Urinary system tumor (mainly prostate cancer) Prostate cancer NCT03289962 BNT122 (personalised cancer vaccine encoding individual tumour mutations) I Individual tumour mutations Active, not recruiting RNA-LPX Good tolerance when used in combination with atezumab; Inducing the release of pro-inflammatory cytokines and peripheral T cell responses in most patients [25]
Blood System Cancer(leukemia mainly) leukemia NCT03468244 Personalized mRNA vaccine encoding neoantigen I Individual tumour mutations Recruiting LPP (lipo subcutaneous plex) nanodelivery Not published
NCT04486378 BNT122 (personalised cancer vaccine encoding individual tumour mutations) II Individual tumour mutations Recruiting RNA-LPX Not published
Digestive System Cancer Colorectal Cancer with Liver Metastases NCT04161755 BNT122 (personalised cancer vaccine encoding individual tumour mutations) With oxaliplatin, irinotecan, fluorouracil, leucovorin, and atezolizumab I Individual tumour mutations Active, not recruiting RNA-LPX Not published
Esophagus Cancer NCT03480152 National Cancer Institute (NCI)-4650, a messenger ribonucleic acid (mRNA)-based, Personalized Cancer Vaccine I/II Individual tumour mutations Terminated Lipid nanoparticles It has safety and immunogenicity, with a maximum tested dose of 0.39 mg and no serious side effects observed

Colorectal

Cancer

NCT04534205

BNT122 (personalised cancer vaccine encoding individual

tumour mutations)

II Individual tumour mutations Recruiting RNA-LPX Not published

Pancreatic

cancer

NCT02316457

BNT-114 plus BNT-122 (personalised set of pre-manufactured

non-mutated shared tumour-associated antigens plus a

personalised cancer vaccine encoding individual tumour mutations)

I Individual tumour mutations Active, not recruiting DC Not published
gastric cancer, esophageal cancer, and liver cancer NCT05192460 neoantigen tumor vaccine I individual tumour mutations Active, not recruiting Unknown Not published
colonic neoplasms and colorectal neoplasms NCT05456165 GRT-C901/GRTR902 II Deoxyribonucleic acid (DNA) mutations present peptides Recruiting Chimpanzee adenovirus Ongoing
Other Cancer TNBC NCT02316457 IVAC_W_bre1_uID and IVAC_M_uID I Tumor-specific mutations Active, not recruiting LPX Ongoing