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Table 1 List of all active, and completed or terminated phase II/III clinical trials of mRNA vaccines in cancer therapy

From: mRNA therapeutics in cancer immunotherapy

Sponsor Vaccine type (delivery route) Indication ClinicalTrial.gov identifier (phase, allocation) Combination Opened Status
DC vaccine
 Antwerp University Hospital WT1 mRNA (i.d.) Myeloid leukemia, multiple myeloma NCT00965224 (II, randomized) Standard-of-care 2009 Unknown [27]
AML NCT01686334 (II, randomized) Conventional chemotherapy 2012 Recruiting
GBM NCT02649582 (I/II) Temozolomide, temozolomide-based chemoradiation 2015 Recruiting
Malignant pleural mesothelioma NCT02649829 (I/II) Conventional chemotherapy 2017 Recruiting
 Argos Therapeutics Total tumor mRNA and CD40L mRNA (i.d.) RCC NCT00678119 (II, single arm) Standard-of-care (sunitinib) 2008 Completed [28]
NCT01582672 (III, randomized) 2012 Terminated (Lack of effiacy) [29, 30]
 Asterias Biotherapeutics, Inc. hTERT mRNA with a LAMP-1 targeting sequence (i.d.) AML (complete remission) NCT00510133 (II, single arm) None 2007 Completed [31]
 Baylor College of Medicine Tumor mRNA and tumor lysate (i.d.) Pancreatic cancer NCT04157127 (I) Adjuvant to chemotherapy 2020 Recruiting
 Duke University LAMP-fused HCMV pp65 mRNA (i.d.) and td Malignant neoplasms of brain NCT00639639 (I) None 2006 Active, not recruiting [32]
NCT02366728 (II, randomized) Temozolomide, basiliximab (antagonistic anti-CD25) 2015 Active, not recruiting [33]
Glioblastoma NCT03688178 (II, randomized) Temozolomide, varlilumab (agonistic anti-CD27) 2020 Recruiting
LAMP-fused HCMV pp65 mRNA, GM-CSF (i.d.) and td Malignant neoplasms of brain NCT03615404 (I) None 2018 Active, not recruiting
Glioblastoma NCT03927222 (II, single arm) Temozolomide 2019 Recruiting
 Guangdong 999 Brain Hospital Tumor mRNA Brain cancer, neoplasm metastasis NCT02808416 (I) None 2016 Active, not recruiting
Recurrent glioblastoma NCT02808364 (I) None 2016 Active, not recruiting
Glioblastoma TAA mRNA (i.d. and i.v.) Glioblastoma NCT02709616 (I) Conventional chemo- and radiotherapy 2016 Active, not recruiting
 Hasumi International Research Foundation IKKb-matured DCs with tumor mRNA, TAA mRNA (gp100, tyrosinase, PRAME, MAGE-A3, IDO) and neoAg mRNA (GNAQ/GNA11Q209 or R183) (i.v.) Uveal metastatic melanoma NCT04335890 (I) None 2020 Recruiting
 Herlev Hospital PSA, PAP, survivin, hTERT mRNA (i.d.) Metastatic prostate cancer NCT01446731 (II, randomized) Docetaxel 2011 Completed [34]
 Immunomic Therapeutics, Inc. HCMV pp65-shLAMP or pp65-flLAMP, GM-CSF and td (both) GBM, glioblastoma, malignant glioma, astrocytoma NCT02465268 (II, randomized) Temozolomide 2016 Recruiting
 Memorial Sloan Kettering Cancer Center Langerhans-type DCs with Trp2 mRNA Melanoma NCT01456104 (I) None 2011 Active, not recruiting
Langerhans-type DCs with CT7, MAGE-A3, WT1 mRNA Multiple myeloma NCT01995708 (I) Standard-of-care 2014 Active, not recruiting
 Oslo University Hospital Tumor mRNA and hTERT, survivin TAA mRNA Prostate cancer NCT01197625 (I/II) None 2010 Active, not recruiting
 Radboud University Tyrosinase, gp100 mRNA (i.d. and i.v.) Melanoma NCT02285413 (II, randomized) Cisplatin 2011 Completed [35]
 University Hospital Erlangen Tumor mRNA Uveal melanoma NCT01983748 (III, randomized) None 2014 Recruiting
 University of Campinas WT1 mRNA Myelodysplastic syndromes, AML NCT03083054 (I/II) None 2016 Active, not recruiting
 University of Florida Total tumor mRNA and ex vivo expanded lymphocytes (i.v. and i.d.) Medulloblastoma, neuroectodermal tumor NCT01326104 (I, II) None 2010 Active, not recruiting [36]
Total tumor mRNA, ex vivo expanded lymphocytes, GM-CSF and td Diffuse intrinsic pontine glioma, Brain stem glioma NCT03396575 (I) Cyclophosphamide + fludarabine lymphodepleting conditioning or temozolomide 2018 Recruiting
 Universitair Ziekenhuis Brussel, Bart Nens MAGE-A3, MAGE-C2, tyrosinase and gp100 mRNA, co-electroporated with TriMix (CD70, CD40L, caTLR4) mRNA Melanoma NCT01302496 (II, single arm) Ipilimumab (antagonistic anti-CTLA-4) 2011 Completed [37,38,39]
Melanoma NCT01676779 (II, randomized) None 2012 Completed [39]
Direct injection of mRNA
 BioNTech SE RNA-LPX with NY-ESO-1, MAGE-A3, tyrosinase and TPTE (i.v.) Advanced melanoma NCT02410733 (I) None 2015 Active, not recruiting [40, 41]
RNA-LPX with TNBC TAAs, p53 and neoAgs (warehouse) (i.v.) TNBC NCT02316457 (I) None 2016 Active, not recruiting
RNA-LPX with ovarian TAAs (i.v.) Ovarian cancer NCT04163094 (I) Carboplatin and paclitaxel 2019 Recruiting
RNA-LPX with prostate TAAs (i.v.) Prostate cancer NCT04382898 (I/II) Cemiplimab (antagonistic anti-PD-1) and/or goserelin acetate 2019 Recruiting
RNA-LPX with HPV16 antigens (i.v.) HPV16+ and PD-L1+ HNSCC NCT04534205 (II, randomized) Pembrolizumab (antagonistic anti-PD-1) 2020 Not yet recruiting
RNA-LPX with NY-ESO-1, MAGE-A3, tyrosinase and TPTE (i.v.) Melanoma NCT04526899 (II, randomized) Cemiplimab 2020 Not yet recruiting
RNA-LPX with CLDN6 (i.v.) Solid tumors NCT04503278 (I/II) CLDN6-specific CAR-T cells 2020 Recruiting
 Genentech Inc., BioNTech SE RNA-LPX with tumor neoAgs (i.v.) Different solid cancers NCT03289962 (I) Atezolizumab (antagonistic anti-PD-L1) 2017 Recruiting
Melanoma NCT03815058 (II, randomized) Pembrolizumab 2019 Recruiting
 Changhai Hospital; Stemirna Therapeutics mRNA encoding neoAg (s.c.) Esophageal squamous carcinoma, gastric-, pancreatic- and colorectal adenocarcinoma NCT03468244 (NA) None 2018 Recruiting
 CureVac AG Protamine-formulated mRNA (RNActive) PSA, PSMA, PSCA, STEAP1, PAP and MUC1 (i.d.) Prostate cancer NCT01817738 (I/II, randomized) None 2012 Terminated [42,43,44]
NCT02140138 (II, randomized) Radical prostatectomy 2014 Terminated (after enrollment of 35/36 patients)
 eTheRNA mRNA encoding tyrosinase, gp100, MAGE-A3, MAGE-C2, and PRAME and TriMix (CD40L, CD70 and caTLR4) mRNA (i.n.) Melanoma NCT03394937 (I) None 2018 Recruiting [45]
 Ludwig Institute for Cancer Research, CureVac AG, Böhringer Ingelheim RNActive encoding NY-ESO-1, MAGE-C1, MAGE-C2, TPBG, survivin, MUC1 (i.d.) Meatastatic NSCLC NCT03164772 (I/II) Durvalumab (antagonistic anti-PD-L1), Tremelimumab (antagonistic anti-CTLA-4) 2017 Recruiting
 Merck Sharp & Dohme Corp. LNP-formulated mRNA encoding different KRAS mutations (i.m.) KRAS-mutant NSCLC, colorectal cancer, pancreatic adenocarcinoma NCT03948763 (I) Pembrolizumab 2019 Recruiting
 ModernaTX Inc., Merck Sharp & Dohme Corp. Lipid-formulated mRNA encoding neoAg (i.m.) Solid tumors NCT03313778 (I) Pembrolizumab 2017 Recruiting [46]
Melanoma NCT03897881 (II, randomized) Pembrolizumab 2019 Recruiting
 University of Florida Lipid-formulated mRNA with tumor and LAMP-fused HCMV pp65 TAA mRNA (i.v.) Adult glioblastoma NCT04573140 (I) None 2020 Not yet recruiting
  1. From ClinicalTrial.gov (keywords: cancer, mRNA, vaccine) on Nov 1, 2020 and PubMed literature search. AML acute myeloid leukemia, ca constitutively active, CLDN6 claudin-6, CTLA-4 cytotoxic T-lymphocyte-associated protein 4, GBM glioblastoma multiforme of brain, GM-CSF granulocyte-macrophage colony stimulating factor, HCMV human cytomegalovirus, HNSCC head and neck squamous cell carcinoma, HPV human papilloma virus, hTERT telomerase reverse transcriptase, i.d. intradermal, i.m. intramuscular, i.n. intranodal, i.v. intravenous, IDO indoleamine-pyrrole 2,3-dioxygenase, IKKb inhibitor of nuclear factor kappa-B kinase subunit beta, LAMP lysosome-associated membrane glycoprotein, MAGE melanoma-associated antigen, MUC1 mucin-1, neoAg neoantigen, NY-ESO-1 New York esophageal squamous cell carcinoma-1, NSCLC non-small-cell lung cancer, PAP prostatic acid phosphatase, PD-1 programmed cell death protein 1, PD-L1 Programmed cell death ligand 1, PRAME melanoma antigen preferentially expressed in tumors, PSA prostate-specific antigen, PSCA prostate stem cell antigen, PSMA prostate-specific membrane antigen, RCC renal cell carcinoma, RNActive Protamine-formulated mRNA, RNA-LPX liposome-formulated mRNA, s.c. subcutanous, STEAP 6-transmembrane epithelial antigen of prostate, TAA tumor-associated antigen, td tetanus-diphtheria toxoid, TLR toll-like receptor, TNBC triple-negative breast cancer, TPBG trophoblast glycoprotein, TPTE transmembrane phosphatase with tensin homology, Trp2 tyrosinase-related protein-2, WT1 Wilm’s tumor protein 1