Table 2.
Early phase clinical studies evaluating the role of mRNA vaccines for non-CHOL cancers
| Antigen | Vehicle | Combination | Indication | n | Outcomes | Clinical trial |
|---|---|---|---|---|---|---|
| WT1 | DC | Durvalumab | Solid tumor Lymphoma | 264 | Increased WT1-specific CD8+ T cells | NCT03739931 [35] |
| WT1, PRAME, and CMVpp65 | DC | – | Acute myeloid leukemia | 13 | Enhanced PRAME and WT1-specific immunity; 5 patients in CR, with an observation period of up to 840 d | NCT01734304 |
| CEA-peptide | LNP | Oxaliplatin/Capecitabine | Colorectal cancer | 30 | CEA peptide-specific T-cells detected in 8/11 patients in the peptide group | NCT00228189 [36] |
| Tumor RNA plus synthetic CD40L RNA | DC | Sunitinib | Renal cell carcinoma | 25 | 13 patients (62%) experienced clinical benefit (PR + CR) | NCT00678119 [37] |
| Tumor-associated antigens | Liposome | PD-1 inhibitor | Melanoma | 119 | Increased antigen-specific cytotoxic T-cell were observed | NCT02410733 [38] |
| Autologous tumor-mRNA | DC | IL-2 | Melanoma | 31 | Antigen-specific immune response demonstrated in 51.6% patients; immune responders had better survival (median 14 months vs. 6 months, P = 0.030) | NCT01278940 [39] |
| CD40 ligand TLR4, gp100 and tyrosinase | DC | – | Melanoma | 28 | 1 PR and 2 SD observed in 8 patients | NCT01530698 [40] |
| MageA3, MageA1, Melan-A, Tyrosinase, Survivin, and gp100 | Protamine-protected | GM-CSF s.c | Melanoma | 20 | Antigen-specific T cells detected in 2/4 evaluable patients; 1 CR observed in 7 patients | NCT00204607 [41] |
| hTERT | DC | – | Acute myeloid leukemia | 21 | 11 patients (58%) developed hTERT-specific T-cell responses | NCT00510133 [42] |
WT1 Wilms’ tumor 1 antigen, DC dendritic cell, CMV cytomegalovirus, PRAME preferentially expressed antigen in melanoma, CR complete response, CEA carcinoembryonic antigen, LNP lipid nanoparticle, RNA ribonucleic acid, PR partial response, PD-1 programmed death-1, IL-2 interleukin-2, TLR4 toll-likereceptor4, gp100 glycoprotein 100, SD stable disease, MageA melanoma-associated antigen, GM-CSF granulocyte–macrophage colony-stimulating factor, s.c. subcutaneous injection, hTERT human telomerase reverse transcriptase, “–” no combined drug