Table 6.
Clinical trials of immunomodulator mRNA.
| Period | Product | Type | Study | Phase | Sponsor | Formulation | Route | Other Therapy | Response |
|---|---|---|---|---|---|---|---|---|---|
| 2017–2023 | CV8102 (mRNA encoding TLR7/8/RIG-I agonist) | advanced solid tumors | NCT03291002 | Phase I | CureVac | non-coding, non-capped RNA | i.t. | anti-PD-1 Ab | well tolerated without dose-limiting toxicities [267] |
| 2017–2019 | CV8102 | HCC | NCT03203005 | Phase I/II | National Cancer Institute, Naples | non-coding, non-capped RNA | i.d. | Cyclophosphamide, IMA970A (multipeptide-based HCC vaccine) | safe with a side effect [268] |
| 2016–2023 | mRNA-2752 (mRNA encoding OX40L, IL-23, and IL-36γ) | high-risk DCIS | NCT02872025 | Phase I | Laura Esserman | LNP | Intralesional injection | Pembrolizumab | well tolerated with slight dose-limiting toxicities [269] |
| 2018–2023 | mRNA-2752 (mRNA encoding OX40L, IL-23, and IL-36γ) | advanced malignancies | NCT03739931 | Phase I | ModernaTX, Inc. | LNP | i.t. | Durvalumab | ongoing |
| 2017–2022 | mRNA-2416 (mRNA encoding OX40L) | relapsed/refractory solid tumor malignancies or lymphoma and OC | NCT03323398 | Phase I/II | ModernaTX, Inc. | LNP | i.t. | Durvalumab | not published |
| 2019–2024 | BNT131 (SAR441000, mRNA encoding IL-12sc, IFNα-2b, GM-CSF, and IL-15sushi) | metastatic neoplasm | NCT03871348 | Phase I | Sanofi | saline-formulated mixture | i.t. | Cemiplimab REGN2810 | ongoing |
| 2019–2027 | MEDI1191 (mRNA encoding IL-12) | advanced solid tumors | NCT03946800 | Phase I | MedImmune LLC | LNP | i.t. | Durvalumab | ongoing |
| 2020–2026 | BNT151 (mRNA encoding IL-2) | solid tumors | NCT04455620 | Phase I/II | BioNTech SE | LPX | i.v. | / | ongoing |
| 2021–2023 | BNT152 (mRNA encoding IL-7) plus BNT153 (mRNA encoding IL-2) | solid tumor | NCT04710043 | Phase I | BioNTech SE | LPX | i.v. | / | ongoing |
| 2022–2027 | ABOD2011 (mRNA encoding IL-12) | advanced solid tumors | NCT05392699 | Phase I | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | naked mRNA | i.t. | / | ongoing |
Abbreviations: i.t., intratumoral injection; i.d., intradermal injection; i.v., intravenous injection; HCC, hepatocellular carcinoma; DCIS, ductal carcinoma in situ; OC, ovarian cancer; LNP, lipid nanoparticle; LPX, lipoplex; TLR 7/8, toll-like receptor 7/8; RIG-I, retinoic-acid-inducible gene I; OX40L, the glycoprotein OX40, OX40 ligand; IL-23, interleukin-23; IL-36γ, interleukin-36 gamma; IL-12sc, interleukin-12sc; IFNα-2b, interferon alpha2b; GM-CSF, granulocyte–macrophage colony-stimulating factor; IL-15sushi, interleukin-15sushi; IL-12, interleukin-12; IL-7, interleukin-7; IL-2, interleukin-2.