Table 3.
mRNA vaccine candidates for cancer therapy currently in clinical trials
| Sponsor | Cancer type | Identifier | Drug administration | Phase | Status |
|---|---|---|---|---|---|
| Duke University | Glioblastoma, malignant glioma | NCT00626483 | CMV pp65-LAMP mRNA-loaded DC + GM-CSF | I | Completed |
| NCT00639639 | CMV-ALT + CMV pp65-LAMP mRNA-loaded DC | I | Active, not recruiting | ||
| NCT02529072 | DC loaded with CMV Ag mRNA in combination with nivolumab | I | Completed | ||
| NCT02366728 | Human CMV pp65-LAMP mRNA-pulsed autologous DCs | II | Active, not recruiting | ||
| Glioblastoma | NCT00890032 | BTSC mRNA-loaded DCs | I | Completed | |
| NCT03927222 | Human CMV pp65-LAMP mRNA-pulsed autologous DCs + temozolomide + Td toxoid + GM-CSF | II | Suspended | ||
| NCT03688178 | Human CMV pp65-LAMP mRNA-pulsed autologous DCs + temozolomide + varlilumab + Td toxoid + 111In-labeled DCs + unpulsed DCs | II | Recruiting | ||
| Melanoma | NCT01216436 | DCs transfected with mRNA encoding TAAs | I | Terminated | |
| Radboud University | Melanoma | NCT00929019 | Autologous DCs EP with mRNA encoding gp100 and tyrosinase | I/II | Terminated |
| NCT00243529 | Autologous DCs transfected with mRNA encoding TAAs | I/II | Completed | ||
| NCT00940004 | DCs EP with mRNA encoding TAAs gp100 and tyrosinase | I/II | Completed | ||
| NCT01530698 | Autologous DCs EP with mRNA | I/II | Completed | ||
| NCT02285413 | DCs loaded with mRNA encoding TAAs gp100 and tyrosinase +/− cisplatinum | II | Completed | ||
| Colorectal cancer | NCT00228189 | CEA mRNA-loaded DCs | I | Completed | |
| Hematological Malignancies | NCT02528682 | MiHA mRNA-loaded PD-L-silenced DC | I/II | Completed | |
| Prostatic Neoplasms | NCT02692976 | DCs loaded with protamine/mRNA encoding KLH + DCs loading with MHC I binding peptides, NY-ESO-1 and MUC1 PepTivator | II | Completed | |
| Oslo University Hospital | Melanoma | NCT00961844 | DCs - transfected with hTERT-, survivin- and tumor cell derived RNA + ex vivo T cell expansion and reinfusion+temozolomide | I/II | Terminated |
| NCT01278940 | mRNA-transfected DCs + IL-2 | I/II | Completed | ||
| Prostate cancer | NCT01197625 | Autologous DCs loaded with mRNA from primary prostate cancer tissue, hTERT, and survivin | I/II | Active, not recruiting | |
| NCT01278914 | mRNA-transfected DCs | I/II | Completed | ||
| Glioblastoma | NCT00846456 | Tumor stem cell-derived mRNA-transfected DCs | I/II | Completed | |
| NCT03548571 | DCs transfected with mRNA encoding survivin and hTERT + temozolomide | II/III | Recruiting | ||
| Ovarian cancer | NCT01334047 | DCs loaded with amplified ovarian cancer stem cell mRNA, hTERT, and survivin | I/II | Terminated | |
| Antwerp University Hospital | AML | NCT00834002 | WT1mRNA-transfected autologous DCs | I | Completed |
| NCT01686334 | DCs EP with autologous WT1 mRNA | II | Recruiting | ||
| AML, CML, multiple myeloma | NCT00965224 | DCs EP with autologous WT1 mRNA | II | Unknown | |
| Multiple solid tumors | NCT01291420 | WT1 mRNA-EP autologous DCs | I/II | Unknown | |
| Mesothelioma | NCT02649829 | DCs loaded with WT1 + chemotherapy | I/II | Recruiting | |
| Glioblastoma | NCT02649582 | Autologous WT1 mRNA-loaded DCs + temozolomide | I/II | Recruiting | |
| Argos Therapeutics | Renal cell carcinoma | NCT01482949 | DC EP with autologous tumor mRNA +/− sunitinib | II | Terminated |
| NCT00678119 | DCs co-EP with CD40L IVT RNA and autologous total tumor RNA + sunitinib | II | Completed | ||
| NCT00272649 | DCs co-EP with CD40L IVT RNA and autologous total tumor RNA | I/II | Completed | ||
| NCT01582672 | DCs EP with Autologous tumor mRNA plus sunitinib | III | Terminated | ||
| NCT00087984 | Autologous tumor total RNA-transfected DCs | I/II | Completed | ||
| Pancreatic cancer | NCT00664482 | Autologous DCs EP with tumor total RNA | NA | Completed | |
| BioNTech | Melanoma | NCT01684241 | Naked RNA encoding TAAs | I | Completed |
| NCT02035956 | Personalized poly-epitopic RNA-based vaccine | I | Completed | ||
| NCT02410733 | Lipo-MERIT, encoding for 4 melanoma associated non-mutated antigens | I | Active, not recruiting | ||
| NCT04526899 | RNA-LPX with NY-ESO-1, MAGE-A3, tyrosinase, and TPTE +/− cemiplimab | II | Recruiting | ||
| Breast cancer | NCT02316457 | RNA-LPX with TNBC TAAs, p53, and neo-Ags | I | Active, not recruiting | |
| Prostate cancer | NCT04382898 | RNA-LPX with prostate TAAs +/− cemiplimab | I/II | Recruiting | |
| CureVac | Prostate cancer | NCT02140138 | CV9104 with or without needle-free injection device | II | Terminated |
| NCT00831467 | RNActive TAAs mRNA CV9103 | I/II | Completed | ||
| NCT01817738 | RNActive TAAs mRNA CV9104 | II/II | Terminated | ||
| NSCLC | NCT00923312 | RNActive TAAs mRNA CV9201 | I/II | Completed | |
| NCT01915524 | RNActive TAAs mRNA CV9202 + local radiation | I | Terminated | ||
| Guangdong 999 Brain Hospital | Glioblastoma | NCT02808364 | Autologous DCloaded with TAA mRNA | I/II | Unknown |
| NCT02709616 | Autologous DC loaded with TAA mRNA | I/II | Unknown | ||
| Brain cancer | NCT02808416 | Personalized cellular vaccine | I | Unknown | |
| Herlev Hospital | Breast cancer, melanoma | NCT00978913 | DCs transfected with hTERT, survivin, and p53 | I | Completed |
| Prostate cancer | NCT01446731 | DCs transfected with PSA, PAP, survivin, and hTERT mRNA+docetaxel | II | Completed | |
| Life Research Technologies | Ovarian cancer | NCT01456065 | DCs loaded with TERT-mRNA and survivin-peptide | I | Unknown |
| Ludwig-Maximilian-University of Munich | AML | NCT01734304 | DCs EP with mRNA encoding WT1, PRAME, and CMVpp65 | I/II | Completed |
| MD Anderson Cancer center | AML | NCT00514189 | Autologous DCs loaded with AML lysate and mRNA | I | Terminated |
| Memorial Sloan Kettering Cancer Center | Melanoma | NCT01456104 | Autologous LCs EP with mRNA encoding TAA | I | Active, notrecruiting |
| Multiple myeloma | NCT01995708 | CT7, MAGE-A3, and WT1 mRNA-EP LCs | I | Active, notrecruiting | |
| Universitair Ziekenhuis Brussel | Melanoma | NCT01066390 | DCs EP with TAA and TriMix mRNA | I | Completed |
| NCT01302496 | DCs EP with TAA and TriMix mRNA + ipilimumab | II | Completed | ||
| NCT01676779 | DC EP with TAA and TriMix mRNA | II | Completed | ||
| University Hospital Erlangen | Melanoma | NCT01983748 | Autologous DCs loaded with tumor mRNA | III | Recruiting |
| University Hospital Tübingen | Melanoma | NCT00204516 | mRNA encoding autologous melanoma associated antigens+GM-CSF | I/II | Completed |
| NCT00204607 | mRNA encoding MART-1, tyrosinase, gp100, MAGEA1, MAGE-A3 and survivin+GM-CSF | I/II | Completed | ||
| Recurrent prostate cancer | NCT02452307 | Peptide vaccine + montanide ISA-51+/−GM-CSF+/− imiquimod +/− mRNA/protamin | I/II | Unknown | |
| University of Campinas | AML, myelodysplastic syndromes | NCT03083054 | Autologous DCs EP with WT1 mRNA | I/II | Active, not recruiting |
| University of Florida | Prostate cancer | NCT00906243 | CV9103 encoding 4 prostate specific antigens | I/II | Terminated |
| Glioblastoma, Malignant Glioma | NCT02465268 | pp65-shLAMP mRNA DCs + GM-CSF | II | Recruiting | |
| Metastatic Prostate Cancer | NCT01153113 | hTERT mRNA transfected DCs | I/II | Withdrawn | |
| Ludwig Institute for Cancer Research | Metastatic NSCLC | NCT03164772 | RNActive TAAs mRNA CV9202 + durvalumab +/−tremelimumab | I/II | Completed |
| Stemirna Therapeutics | Esophageal Cancer, NSCLC | NCT03908671 | Personalized mRNA vaccine encoding neoAg | NA | Not yet recruiting |
| Hospital Affiliated to the Academy of Military Medical Sciences | Esophagus Cancer | NCT02693236 | Adenovirus-transfected autologous DCs + CIK cells | I/II | Unknown |
| NSCLC with bone metastases | NCT02688686 | SOCS1, MUC1 and survivin mRNA-loaded DCs + cytokine-induced killer | I/II | Unknown | |
| University Medical Center Groningen | Ovarian Cancer | NCT04163094 | RNA-LPX with ovarian TAAs + carboplatin/paclitaxel | I | Recruiting |
| ModernaTX, Inc. | Melanoma | NCT03897881 | mRNA-4157 encoding neoAg + pembrolizumab | II | Recruiting |
| Solid tumors | NCT03313778 | mRNA-4157 encoding neoAg +/− pembrolizumab | I | Recruiting | |
| Asterias Biotherapeutics | AML | NCT00510133 | DCs transfected with hTERT mRNA with a LAMP-1 targeting sequence | II | Completed |
| National Cancer Institute | Melanoma, Colon Cancer, Gastrointestinal Cancer, Genitourinary Cancer, Hepatocellular Cancer | NCT03480152 | Personalized cancer mRNA vaccine NCI-4650 | I/II | Terminated |
| Changhai Hospital | Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Colorectal Adenocarcinoma | NCT03468244 | Personalized mRNA vaccine encoding neoAg | NA | Recruiting |
AML: acute myeloid leukemia; WT1: Wilms tumor 1; CML: chronic myeloid leukemia; DCs: dendritic cells; EP: electroporated; CD40L: CD40 ligand; IVT: in vitro transcribed; hTERT: human telomerase reverse transcriptase; LAMP-1: lysosome-associated membrane protein 1; TNBC: triple-negative breast cancer; TAA: tumor-associated antigen; CMV: cytomegalovirus; GM-CSF: granulocyte-macrophage colony-stimulating factor; BTSC: brain tumor stem cell; Td: tetanus-diphtheria; PSA: prostate-specific antigen; PAP: prostatic acid phosphatase; PRAME: melanoma antigen preferentially expressed in tumors; LCs: langerhans cells; CEA: carcinoembryonic antigen; KLH: keyhole limpet hemocyanin; TriMix: CD40L, CD70, and constitutively active TLR4 mRNA; NA: not applicable; SOCS: suppressor of cytokine signaling; neoAg: personalized neoantigen; NSCLC: non-small-cell lung cancer.