Table 2 Currently recruiting studies using mRNA vaccines in tumor therapy
From: Clinical and immunological effects of mRNA vaccines in malignant diseases
mRNA encoding for | Vehicle | Entity | Concept | Reference |
|---|---|---|---|---|
OX40L, IL-23, and IL-36γ | LNP | Dose escalation: r/r solid tumor or lymphoma Dose expansion: triple negative BC, HNSC, NHL and urothelial cancer | mRNA-2752 +/- durvalumab (phase 1) | NCT03739931 |
individually designed mRNA coding for tumor neoantigens | LNP | melanoma | mRNA4157 +/- pembrolizumab (phase 2) | NCT03897881 |
individually designed mRNA coding for tumor neoantigens | LNP | solid tumors: pat. with resected solid tumors and in combination with pembrolizumab in pat. with unresectable solid tumors | mRNA4157 +/-pembrolizumab (phase 1) | NCT03313778 |
KRAS G12D, G12V, G13D, and G12C | LNP | KRASmut NSCLC, CRC or PancCA | mRNA-5671/V941+/- Pembrolizumab (phase 1) | NCT03948763 |
NY-ESO-1, MAGE-C1, MAGE-C2, survivin, 5T4, and MUC-1 | Protamine | NSCLC | mRNA vaccine BI 1361849 + durvalumab +/- tremelimumab (phase 1/2) | NCT03164772 |
CD70, CD40L, and constitutively active TLR4 | Naked mRNA encoding DC activating proteins | Early breast cancer and accessible tumor lesions | TriMix vs placebo (phase 1) | NCT03788083 |
W_ova1 Vaccine (includes 3 OC TAA RNAs) | Liposome | Ovarian cancer | Only treatment arm mRNA + chemotherapy (phase 1) | NCT04163094 |
tyrosinase, gp100, MAGE-A3, MAGE-C2, and PRAME + CD70, CD40L, and constitutively active TLR4 | LNP | Melanoma | ECI-006 intranodal injection with different doses and frequencies following surgical resection, and in patients with stable disease after standard of care immunotherapy treatment + anti-PD1 (cohort 2) | NCT03394937 |
Wt1 | DC | AML | Autologous WT1 mRNA electroporated DCs during 2 years with repeated injection vs no intervention (phase 2) | NCT01686334 |
5 antigens expressed in de novo and metastatic prostate cancer | liposomes | PCA | W_pro1 in patients with metastatic castration resistant prostate cancer +/- Cemiplimab and/or goserelin acetate in patients with high-risk, localized prostate cancer | NCT04382898 |
survivin, hTERT and autologous tumor stem cells derived from tumorspheres | DC | Glioblastoma | Trivalent (temodal/irradiation +-vaccination) in primary treated patients with IDH wild-type, MGMT-promotor methylated glioblastoma (phase 1/2) | NCT03548571 |
PD-L1/L2-silenced, MiHA mRNA | DC | Hematological malignancies after allo HSCT | Vaccination with PD-L1/L2-silenced minor histocompatibility antigen-loaded donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem cell transplantation (a Phase I/II Study) | NCT02528682 |
WT1 | DC | Malignant pleural mesothelioma | DC vaccination + chemotherapy | NCT02649829 |
WT1 | DC | Glioblastoma | Newly diagnosed glioblastoma when autologous WT1 mRNA-loaded DC vaccination is added to adjuvant temozolomide maintenance treatment following (sub)total resection and temozolomide-based chemoradiation | NCT02649582 |
pp65-lysosomal-associated membrane protein | DC | Glioblastoma | pp65-shLAMP mRNA DCs with GM-CSF + Td or pp65-flLAMP mRNA DC with GM-CSF + Td or unpulsed PBMC and saline + temodal (phase 2) | NCT02465268 |
pp65-lysosomal-associated membrane protein | DC | Glioblastoma | Human CMV pp65-LAMP mRNA pulsed autologous DCs Preconditioning with unpulsed DC vs. Td toxoid vs. varlilumab | NCT03688178 |
Total tumor mRNA | DC | Glioblastoma | TMZ during RT and TTRNA pulsed DC´s +Td+GMCSF during and after maintenance cycles of dose-intensive TMZ vs. focal radiotherapy alone and TTRNA pulsed DC´s +Td+GMCSF without maintenance DI TMZ | NCT03396575 |
Up to 20 neoantigens (individualized) | LNP | Solid tumors | RO7198457 +- Atezolizumab (phase 1) | NCT03289962 |
Up to 20 neoantigens (individualized) | LNP | Melanoma | RO7198457 +- Pembrolizumab (phase 2) | NCT03815058 |