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. 2022 May 18;28(18):3929–3939. doi: 10.1158/1078-0432.CCR-21-3304

Table 2.

Overview of active and recruiting clinical trials using mRNA-based therapeutics.

IT type Cancer Study Phase Target Formulation Combination
CAR Solid tumors NCT04981691 Phase I MESO EP autologous T cells NA
Vaccine NSCLC, CRC, PDAC NCT03948763 Phase I KRAS V941 mRNA Pembrolizumab
siRNA (CAS3/SS3) B-cell NHL NCT04995536 Phase I TLR9, STAT3 siRNA linked to CpG oligonucleotide Radiotherapy
Synthetic naked mRNA BC NCT03788083 Phase I TriMix NA NA
Vaccine OC NCT04163094 Phase I 3 OC TAA LNP Carboplatin/paclitaxel
Vaccine Esophageal, NSCLC NCT03908671 Pilot study Neoantigen Undisclosed NA
Vaccine Melanoma NCT03897881 Phase II Neoantigen LNP Pembrolizumab
Vaccine Solid tumors NCT03313778 Phase I Neoantigen LNP Pembrolizumab
Vaccine Melanoma NCT03815058 Phase II Neoantigen RNA-LPX Pembrolizumab
Vaccine Melanoma NCT02410733 Phase I 4 TAA RNA-LPX NA
Vaccine Prostate NCT04382898 Phase I/II 5 PC TAA LNP Cemiplimab
Vaccine Esophageal, gastric cancer, CRC, PC NCT03468244 Pilot study Neoantigen Undisclosed NA
Vaccine GBM NCT03688178 Phase II CMV pp65  mRNA-Loaded autologous DC Varlilumab
Vaccine GBM NCT02649582 Phase I/II WT-1 mRNA-Loaded autologous DC Temozolomide
Vaccine NSCLC NCT03164772 Phase I/II 6 NSCLC TAA BI 1361849 Durvalumab, tremelimumab
Vaccine Melanoma NCT01456104 Phase I Melanoma TAA Autologous LC EP with TAA mRNA NA
Vaccine GBM NCT03927222 Phase II CMV Pp65-LAMP mRNA-loaded autologous DC Temozolomide, GM-CSF Tetanus-diphteria, toxoid
Vaccine GMB NCT02465268 Phase II CMV Pp65-shLAMP mRNA-loaded DC GM-CSF
Vaccine Brain metastasis NCT02808416 Phase II Neoantigen mRNA tumor antigen pulsed DC NA
Vaccine GBM NCT00639639 Phase I CMV Pp65-LAMP mRNA-loaded autologous DC Tetanus toxoid
Vaccine PC NCT01197625 Phase I/II Tumor antigen Tumor mRNA-loaded DC hTERT Survivin
Vaccine AML NCT01686334 Phase I/II WT1 antigen mRNA EP autologous DC (Potentially) low-dose chemotherapy
Vaccine MM NCT01995708 Phase I CT7, MAGE-A3, WT1 mRNA EP autologous LC Standard of care
Vaccine AML, HRMS NCT03083054 Phase I/II WT1 antigen mRNA EP autologous DC NA
Vaccine NSCLC, GEA, mUC, MSS-CRC NCT03639714 Phase I/II Neoantigen SAM ChAd, nivolumab, ipilimumab
Vaccine MSS-CRC, NSCLC, PDAC NCT03953235 Phase I/II Shared neoantigen Kras SAM ChAd, nivolumab, ipilimumab
Vaccine CRC NCT05141721 Phase II/III Neoantigen SAM ChAd, standard of care atezolizumab, ipilimumab
RNAi PDAC NCT01676259 Phase II KRAS siG12D-LODER Gemcitabine, paclitaxel, FOLFIRINOX
RNAi Advanced malignant solid neoplasms NCT01591356 Phase I EPHA2 DOPC encapsulation NA
Vaccine Melanoma NCT02410733 Phase I NYESO-1, MAGE A3 tyrosinase, TPTE Lipo-MERIT NA
Vaccine Melanoma NCT03815058 Phase II Neoantigen Lipoplex Pembrolizumab
mAB Solid tumors NCT04683939 Phase I/II CLDN18.2 Undisclosed Paclitaxel, gemcitabine
Immune inducers Solid tumors, lymphoma NCT03739931 Phase I/II NA OX40L, IL23, IL36y coding mRNA Durvalumab

Note: Data from Meisel et al. (74) and Wang et al. (76).

Abbreviations: BC, breast cancer; ChAd, chimpanzee adenovirus; CMV, cytomegalovirus; EP, electroporated; GBM, glioblastoma multiforme; GEA, gastroesophageal adenocarcinoma; HRMS, high-risk myelodysplastic syndrome; IT, immunotherapy; LCs, Langerhans cells; AML, acute myeloid leukemia; MESO, mesothelin; MSS-CRC, microsatellite stable colorectal cancer; mUC, metastatic urothelial carcinoma; NA, not applicable; NHL, non-Hodgkin lymphoma; NSCLC, non–small cell lung carcinoma; OC, ovarian cancer; PC, prostate cancer; PDAC, pancreatic ductal adenocarcinoma; pHGG, pediatric high-grade glioma; STAT3, signal transducer and activator of transcription 3; TAA, tumor-associated antigens; TLR9, Toll-like receptor 3.

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