TABLE 1.
Summary of clinical studies of mRNA‐based cancer immunotherapy.
| Name of product | CTrials.gov identifier | Payload/delivery platform | Cancer type | Study phase | Patients, n | Latest time | Ref. |
|---|---|---|---|---|---|---|---|
| ECI‐006 | NCT03394937 | Intranodal injection of nacked TriMix and TAAs‐mRNA | Resected melanoma | I | 21 | 2021 | [210] |
| IVAC MUTANOME | NCT02035956 | Intranodal injection of nacked mRNA encoding individual mutant neoantigens | Advanced melanoma | I | 15 | 2020 | [211] |
| CV9202 | NCT01915524 | Protamine with local irradiation | NSCLC | I | 26 | 2016 | [212] |
| mRNA‐4157 | NCT03897881 | Mutated neoepitope mRNA‐LNP with pembrolizumab | Melanoma | II | 157 | 2023 | [213] |
| NCI‐4650 | NCT03480152 | Neoantigen‐specific mRNA‐LNP | Several tumors | I‐II | 5 | 2020 | [214] |
| mRNA‐5671 | NCT03948763 | mRNA‐LNP with pembrolizumab | Several tumors | I | 70 | 2022 | [215] |
| PNOC020 | NCT04573140 | Tumor mRNA and pp65 LAMP‐loaded LNP | Glioblastoma | I | 28 | 2023 | [216] |
| BNT111 | NCT04526899 | mRNA‐lipoplex with cemiplimab | Unresectable melanoma | I | 180 | 2023 | [217] |
| BNT112 | NCT04382898 | mRNA‐lipoplex cancer vaccine with cemiplimab | Prostate cancer | I‐II | 115 | 2023 | [218] |
| BNT113 | NCT04534205 | mRNA‐lipoplex with pembrolizumab | Head and neck cancer | II | 285 | 2023 | [219] |
| BNT116 | NCT05142189 | mRNA‐lipoplex with cemiplimab and docetaxel | NSCLC | I | 80 | 2023 | [220] |
| BI 1361849 | NCT03164772 | TAAs‐mRNA loaded protamine | Metastatic NSCLC | I‐II | 61 | 2022 | [206] |
| CV9104 | NCT01817738 | Antigen‐mRNA loaded protamine | Prostate cancer | I‐II | 197 | 2017 | [221] |
| CV9201 | NCT00923312 | Antigen‐mRNA loaded protamine | NSCLC | I‐II | 46 | 2018 | [222] |
| TERT‐mRNA | NCT01456065 | Survivin‐peptide | Ovarian epithelial cancer | I | 15 | 2013 | [223] |
| GRNVAC1 | NCT00510133 | Autologous dendritic cell vaccine | AML | II | 21 | 2019 | [224] |
| mRNA‐transfected DC | NCT00929019 | Dendritic cell vaccination | Uveal melanoma | I‐II | 23 | 2018 | [225] |
| mRNA‐4157 | NCT03313778 | mRNA‐LNP with pembrolizumab | Solid tumors | I | 108 | 2023 | [226] |
| RO7198457 | NCT03289962 | mRNA‐lipoplex with atezolizumab | Melanoma, pancreatic cancer, etc. | I | 272 | 2023 | [227] |
| V940 (mRNA‐4157) | NCT05933577 | mRNA‐LNP with pembrolizumab | Melanoma | III | 1089 | 2023 | [228] |
Abbreviations: AML: acute myelogenous leukemia; LAMP: lysosomal associated membrane protein; NSCLC: non‐small cell lung cancer; TAAs: tumor‐associated antigens.