Table 4.
mRNA cancer vaccines registered on clinicaltrials.gov.
| Target antigen | Cancer type | Phase | NCT number | Results |
|---|---|---|---|---|
| mRNA cancer vaccines encoding TAAs | ||||
| NY-ESO-1, tyrosinase, MAGE-A3, TPTE | Advanced melanoma | Phase I | NCT02410733 | Lipo-MERIT is safe and well-tolerated in patients with advanced melanoma |
| BNT113 (HPV16 E6 and E7 proteins) | Unresectable recurrent, or metastatic head and neck squamous cell carcinoma | Phase II | NCT04534205 | Recruiting |
| BNT113 (HPV16 E6 and E7 proteins) | Human papillomavirus-related carcinomaHead and neck neoplasmCervical neoplasmPenile neoplasms malignantUnknown primary tumors | Phase I/II | NCT03418480 | BNT1113 showed acceptable safety and tolerability in patients with head and neck neoplasm |
| BNT114 plus BNT122 (personalized set of premanufactured non-mutated shared TAA plus a personalized cancer vaccine) | TNBC | Phase I | NCT02316457 | BNT114 showed acceptable safety and tolerability, along with a temporary increase in cytokine levels |
| BNT112 (PAP, PSA, PSMA, NKX3.1, HOXB13) | Prostate cancer | Phase I/II | NCT04382898 | BNT112 alone or with cemiplimab has shown good safety in prostate cancer patients |
| BNT111(NY-ESO-1, tyrosinase, MAGE-A3, and TPTE) | Melanoma stage IIIMelanoma stage IVUnresectable melanoma | Phase I | NCT04526899 | BNT111 possesses improvement in ORR in the combination therapy with cemiplimab, showing good safety whether used alone or in combination |
| Ovarian cancer TAA | Ovarian cancer | Phase I | NCT04163094 | W_ova1 vaccine showed good immune response and tolerability in ovarian cancer patients, but then it was terminated |
| mRNA-4359 (IDO1, PD-L1) | Advanced solid tumors | Phase I/II | NCT05533697 | mRNA-4359 holds promise in controlling tumor progression in patients with advanced solid tumors |
| mRNA cancer vaccines encoding TSAs | ||||
| BNT122 (personalized cancer vaccine encoding TSA) | MelanomaNon-small cell lung cancerBladder cancerColorectal cancerTNBCRenal cancerHead and neck cancerOther solid cancers | Phase I | NCT03289962 | BNT122 is safe and well-tolerated in advanced solid tumors |
| BNT122 (personalized cancer vaccine encoding TSA) | Colorectal cancer stage II/III | Phase II | NCT04486378 | BNT122 in combination with atezolizumab demonstrates good immunogenicity and safety |
| mRNA-4157 (personalized cancer vaccine encoding TSA) | Solid tumors | Phase II | NCT03313778 | mRNA-4157 has an acceptable safety profile along with observed clinical responses in combination with pembrolizumab |
| mRNA-4157 (personalized cancer vaccine encoding TSA) | Melanoma | Phase II | NCT03897881 | mRNA-4157 combined with pembrolizumab can prolong RFS in high-risk melanoma patients postresection |
| mRNA cancer vaccines encoding immunomodulators | ||||
| CD40L, CD70, caTLR4; melanoma-TAA, gp100, MAGE-A3, MAGE-C2, and PRAME | Melanoma | Phase I | NCT03394937 | ECI-006 is safe and well-tolerated in advanced melanoma |
| mRNA-2752 (OX40L, IL-23, IL-36γ) | Relapsed/refractory solid tumor malignancies or lymphoma | Phase I | NCT03739931 | mRNA-2752 is well tolerated in patients with solid tumors and exhibits sustained immunomodulatory effects |
| mRNA-2752 (OX40L, IL-23, IL-36γ) | Carcinoma, intraductal, non-infiltrating | Early phase I | NCT02872025 | Recruiting |
| mRNA cancer vaccines encoding CARs or TCR | ||||
| MET CARs with tandem TCRζ and 4-1BB | Malignant melanomaBreast cancer | Early phase I | NCT03060356 | RNA CART-cMET is safe and feasible in patients with metastatic melanoma |
| HBV-specific T-cell receptor (TCR | Recurrent hepatocellular carcinoma | Phase I | NCT02719782 | Unpublished results |
| MESO CAR T-cell | Refractory malignant solid neoplasm | Phase I | NCT04981691 | Unpublished results |
| Allogeneic NKG2DL-targeting CAR-grafted γδ T cells | CancerMalignancyRefractory cancerRelapsed cancer | Phase I | NCT05302037 | Unknown status |
CAR: Chimeric antigen receptor; HOXB13: Homeobox B13; IDO: Indoleamine 2,3-dioxygenase; IL-23: Interleukin-23; IL-36γ: Interleukin-36 gamma; MAGE-A3: Melanoma-associated antigen A3 tyrosinase; MAGE-C2: Melanoma antigen gene-C2; MESO: Anti-mesothelin; mRNA: Messenger RNA; NKG2DL: Natural killer group 2 member D ligand; NKX31: NK3 homeobox 1; NY-ESO-1: New York esophageal squamous cell carcinoma 1; ORR: Overall response rate; PAP: Prostatic acid phosphatase; PD-L1: Programmed death-ligand 1; PSA: Prostate-specific antigen; PSMA: Prostate-specific membrane antigen; RFS: Recurrence-free survival; TAAs: Tumor-associated antigens; TCR: T-cell receptor; TLR: Toll-like receptor; TNBC: Triple-negative breast cancer; TPTE: Transmembrane phosphatase with tensin homology; TSA: Tumor-specific antigen.