Table 1.
Clinical trials of neoantigen mRNA.
| Period | Product | Type | Study | Phase | Sponsor | Formulation | Route | Other Therapy | Response |
|---|---|---|---|---|---|---|---|---|---|
| 2020–2023 | IVAC_W_bre1_uID and IVAC_M_uID | TNBC | NCT02316457 | Phase I | BioNTech SE | LPX | i.v. | / | ongoing |
| 2017–2019 | IVAC MUTANOME, RBL001/RBL002 (BNT121) | melanoma | NCT02035956 | Phase I | BioNTech SE | naked mRNA | i.n. | / | not published |
| 2017–2024 | Autogene cevumeran (RO7198457, BNT122) | solid tumors | NCT03289962 | Phase I | Genentech, Inc. | naked mRNA | i.v. | Atezolizumab | ongoing |
| 2017–2025 | mRNA-4157 | solid tumors | NCT03313778 | Phase I | ModernaTX, Inc. | LNP | i.m. | Pembrolizumab | ongoing |
| 2018–2020 | NCI-4650 | solid tumors | NCT03480152 | Phase I/II | National Cancer Institute (NCI) | / | i.m. | / | safe with a slight adverse event [209] |
| 2018–2021 | personalized mRNA tumor vaccine | solid tumors in digestive system | NCT03468244 | NA | Changhai Hospital | LPP | s.c. | / | not published |
| 2019–2024 | RO7198457 | advanced melanoma | NCT03815058 | Phase II | Genentech, Inc. | LPX | i.v. | Pembrolizumab | ongoing |
| 2019–2024 | mRNA-4157 | high risk of recurrence melanoma | NCT03897881 | Phase II | ModernaTX, Inc. | naked mRNA | / | Pembrolizumab | ongoing |
| 2019–2022 | personalized mRNA tumor vaccine | esophageal cancer, NSCLC | NCT03908671 | / | Stemirna Therapeutics | LPP | s.c. | / | not published |
| 2019–2023 | RO7198457 | pancreatic cancer | NCT04161755 | Phase I | Memorial Sloan Kettering Cancer Center | LPX | / | Atezolizumab, chemotherapy (mFOLFIRINOX) | ongoing |
| 2020–2025 | RO7198457 | NSCLC | NCT04267237 | Phase II | Hoffmann-La Roche | LPX | i.v. | Atezolizumab | withdrawn |
| 2022–2023 | SW1115C3 | solid tumor | NCT05198752 | Phase I | Stemirna Therapeutics | LPP | / | / | ongoing |
| 2022–2025 | neoantigen tumor vaccine | gastric cancer, esophageal cancer, and liver cancer | NCT05192460 | / | Jianming Xu | / | / | PD-1/L1 drugs | ongoing |
| 2022–2026 | GRT-C901/GRT-R902 | colonic neoplasms and colorectal neoplasms | NCT05456165 | Phase II | Gritstone bio, Inc. | chimpanzee adenovirus | i.m | Atezolizumab, Ipilimumab, chemotherapy | ongoing |
| 2019–2025 | RO7198457 | NSCLC | NCT04267237 | Phase II | Hoffmann-La Roche | LPX | i.v. | Atezolizumab | ongoing |
| 2019–2024 | RO7198457 | melanoma | NCT03815058 | Phase II | Genentech, Inc. | LPX | i.v. | Pembrolizumab | ongoing |
Abbreviations: i.v., intravenous injection; i.n., intranodal injection; i.m., intramuscular injection; s.c., subcutaneous injection; TNBC, triple-negative breast cancer; NSCLC, non-small-cell lung cancer; LPX, lipoplex; LNP, lipid nanoparticle; LPP, lipopolyplex.