Table 2 Clinical Trials of mRNA Encoding TAAs
Brand | NCT Number | Status | Phases | Disease | Antigen | mRNA | Formulation Type | Route | Combo | Sponsor (s) | Study Results |
|---|---|---|---|---|---|---|---|---|---|---|---|
CV9201 | NCT00923312 | Completed | Phase 1/2 | Stage IIIB/IV NSCLC | MAGE-C1, MAGE-C2, NY-SEO-1, survivin, 5 T4 | mRNA | RNActive, (Protamine) | i.d. | NA | CureVac | CV9201 was well-tolerated and immune responses were detected after treatment. Median progression-free and overall survival were 5 and 10.8 months |
CV9202 | NCT03164772 | Recruiting | Phase 1/2 | NSCLC | NY-ESO-1, MAGE-C1, MAGE-C2, 5 T4, survivin, MUC1 | mRNA | RNActive, Protamine | i.d. | Durvalumab; Tremelimumab | CureVac | CV9202 was well-tolerated, and antigen specific immune responses were detected in majority of patients (84%) |
CV9103 | NCT00831467 | Completed | Phase I/2 | Prostate cancer | PSA, PSCA, PSMA, STEAP1 | mRNA | RNActive, Protamine | i.d. | NA | CureVac | CV9103 is well tolerated and immunogenic |
CV9104 | NCT01817738 | Terminated | Phase I/2 | Prostate cancer | PSA, PSCA, PSMA, STEAP1, PAP, MUC1 | mRNA | RNActive, Protamine | i.d. | NA | CureVac | Terminated due to insufficient activities |
BNT111 (Lipo-MERIT) | NCT02410733 | Active, not yet recruiting | Phase 1 | advanced melanoma | NY-ESO-1, MAGE-C3, tyrosinase, gp100 | mRNA | Lipo-MERIT, DOTMA (DOTAP)/ DOPE lipoplex | i.v. | NA | BioNTech | Not available |
IVAC | NCT02316457 | Active, not yet recruiting | Phase 1 | TNBC | 3 TAAs selected | mRNA | Lipo-MERTI, DOTMA(DOTAP)/DOPE lipoplex | i.v. | NA | BioNTech | Not available |
Not available | NCT01995708 | Active, not yet recruiting | Phase 1 | malignant melanoma | CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells (LCs) | dendritic cell (DC)-loaded mRNA | CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells (LCs) | i.d. | NA | Memorial Sloan Kettering Cancer Center | Not available |
Not available | NCT00204516 | Completed | Phase 1/2 | melanoma | TAA for melanoma (Melan-A, Mage-A1, Mage-A3, survivin, GP100, and tyrosinase) | naked mRNA | naked mRNA | i.d. | GM-CSF | The Norwegian Radium Hospital | Not available |
NA | NCT01278940 | Completed | Phase 1/2 | melanoma | TAA-transfected DC | dendritic cell (DC)-loaded mRNA | DC loaded mRNA | i.d. or i.n. | IL-2 | Oslo University Hospital | Not available |
AVX701 | NCT01890213 | Completed | Phase 1 | Stage III CRC | an alphavirus replicon (VRP) encoding the protein (CEA) | SAM | VRP | i.m. | NA | AlphaVax | Not available |
AVX701 | NCT00529984 | Completed | Phase 1/2 | Advanced or metastatic CEA expressing solid tumor | an alphavirus replicon (VRP) encoding the protein (CEA) | SAM | VRP | i.m. | NA | AlphaVax | Five-year survival for patients with stage IV and stage III cancer was 17, 75%, respectively. All patients shown CEA-specific humoral immunity. CEA-specific, IFNγ-producing CD8 + granzyme B + TCM cells were increased. So, VRP-CEA induces antigen-specific effector T cells while decreasing Tregs, suggesting favorable immune modulation. |