Table 1.
Clinical trials for mRNA therapies
| Company or institution | Disease | Mode of administration | Study phase | Clinical trials–gov identifier/trial number | References |
|---|---|---|---|---|---|
| Moderna | Zika virus | Intramuscular | Phase I/II | NCT03014089 | (Kowalski et al. 2019) |
| Moderna | Human metapneumovirus and parainfluenza infection | Intramuscular | Phase I | NCT03392389 | (Kowalski et al. 2019) |
| Moderna | Influenza H10 | Intramuscular | Phase I | NCT03076385 | (Kowalski et al. 2019) |
| Moderna | Influenza H7 | Intramuscular | Phase I | NCT03345043 | (Kowalski et al. 2019) |
| Moderna | Chikungunya virus | Intramuscular | Phase I | NCT03325075 | (Zhong et al. 2018) |
| Moderna | Chikungunya virus | Intravenous | Phase I | NCT03829384 | (Hou et al. 2021) |
| Moderna | Cytomegalovirus infection | Intradermal | Phase I | NCT03382405 | (Kowalski et al. 2019) |
| Moderna | Solid tumor | Intradermal | Phase I | NCT03313778 | (Kowalski et al. 2019) |
| Moderna | Solid tumor maliganancies or lymphoma | Intratumoral | Phase II | NCT03323398 | (Kowalski et al. 2019) |
| Moderna |
Melanoma; Colon cancer; Genitourinary cancer; Gastrointestinal cancer; Hepatocellular cancer |
Intramuscular | Phase I/II | NCT03480152 | (Kowalski et al. 2019) |
| Moderna | SARS-CoV-2 | Intramuscular | Phase III (EUA and CMA) | NCT04470427 | (Barbier et al. 2022) |
| BioNTech and Pfizer | SARS-CoV-2 | Intramuscular | Phase III (EUA and CMA) | NCT04368728 | (Kim et al. 2021) |
| CureVac | SARS-CoV-2 | Intramuscular | Phase III | NCT04652102 | (Barbier et al. 2022) |
| Medical Research Council, Clinical Trials Unit, UCL (UK) | SARS-CoV-2 | Intramuscular | Phase I | ISRCTN17072692 | (Kim et al. 2021) |
| Arcturus Therapeutics, Inc | SARS-CoV-2 | Intramuscular | Phase II | NCT04728347 | (Hou et al. 2021) |
| Academy of Military Medical Sciences (China) | SARS-CoV-2 | Intramuscular | Phase I | ChiCTR2000034112 | (Kim et al. 2021) |
| Moderna | Respiratory syncytial virus | Intramuscular | Phase I | NCT04528719 | (Hou et al. 2021) |
| Moderna | Cytomegalovirus | Intramuscular | Phase II | NCT04232280 | (Hou et al. 2021) |
| CureVac | Rabies virus | Intramuscular | Phase I | NCT03713086 | (Gómez-Aguado et al. 2020) |
| Merck Sharp & Dohme Corp |
Non-small-cell lung cancer; Colorectal cancer; Pancreatic adenocarcinoma |
Intramuscular | Phase I | NCT03948763 | (Lorentzen et al. 2022) |
| Moderna | Melanoma | Intramuscular | Phase II | NCT03897881 | (Lorentzen et al. 2022) |
| BioNTech RNA Pharmaceuticals GmbH | Melanoma | Intravenous | Phase I | NCT02410733 | (Kowalski et al. 2019) |
| University Medical Center Groningen | HPV(human papillomavirus)-positive cervical cancers | – | Phase I | NCT03141463 | (Chabeda et al. 2018) |
| BioNTech | Ovarian cancer | Intravenous | Phase I | NCT04163094 | (Lorentzen et al. 2022) |
| Genentech, Inc | Melanoma | Intravenous | Phase II | NCT03815058 | (Lorentzen et al. 2022) |
| Moderna | Solid tumor | Intratumoral | Phase I | NCT03739931 | (Hou et al. 2021) |
| MedImmune LLC | Solid tumor | Intratumoral | Phase I | NCT03946800 | (Hou et al. 2021) |
| Sanofi | Solid tumor | Intratumoral | Phase I | NCT03871348 | (Hou et al. 2021) |
| Moderna | Methylmalonic acidaemia | Intravenous | Phase II | NCT03810690 | (Gómez-Aguado et al. 2020) |
| Moderna | Propionic acidaemia | Intravenous | Phase I/II | NCT04159103 | (Gómez-Aguado et al. 2020) |
| Translate Bio, Inc | Ornithine transcarbamylase deficiency | Intravenous | Phase I/II | NCT03767270 | (Gómez-Aguado et al. 2020) |
| Translate Bio, Inc | Cystic fibrosis | Inhalation | Phase I/II | NCT03375047 | (Gómez-Aguado et al. 2020) |
| Intellia Therapeutics | Transthyretin amyloidosis with polyneuropathy | Intravenous | Phase I | NCT04601051 | (Hou et al. 2021) |
| CureVac | Rabies | Intramuscular or Intradermal | Phase I | NCT02241135 | (Kowalski et al. 2019) |
| CureVac | NSCLC (Non-small-cell lung cancer) | Intradermal | Phase I/II | NCT00923312 | (Kowalski et al. 2019) |
| CureVac | NSCLC | Intradermal | Phase I/II | NCT03164772 | (Kowalski et al. 2019) |
| CureVac | Prostate cancer | Intradermal | Phase I/II | NCT00831467/EudraCT 2008-003967-37 | (Kowalski et al. 2019) |
| CureVac | Prostate cancer | Intradermal | Phase II | NCT02140138 | (Kowalski et al. 2019) |
| BioNTech | HPV-driven squamous cell carcinoma | Ultrasound-guided intraneural route | Phase I/II | NCT03418480 | (Gómez-Aguado et al. 2020) |
| BioNTech | TNBC (Triple-negative breast cancer) | Intravenous | Phase I | NCT02316457 | (Kowalski et al. 2019) |
| BioNTech |
Melanoma; NSCLC; Bladder cancer |
Intravenous | Phase I | NCT03289962 | (Gómez-Aguado et al. 2020) |
| BioNTech | Melanoma | Ultrasound-guided intraneural route | Phase I | NCT01684241 | (Gómez-Aguado et al. 2020) |
| BioNTech | Melanoma | Ultrasound-guided intraneural route | Phase I | NCT02035956 | (Gómez-(Aguado et al., 2020) |
| Hospital Clínic de Bacelona | HIV infection | Intradermal | Phase I | NCT02413645 | (Gómez-Aguado et al. 2020) |
| Memorial Sloan Kettering Cancer Center | Multiple myeloma | Intradermal | Phase I | NCT01995708 | (Lorentzen et al. 2022) |
| Memorial Sloan Kettering Cancer Center | Malignant melanoma | Intradermal | Phase I | NCT01456104 | (Wang et al. 2022) |
| Massachusetts General Hospital | HIV infection | Intradermal | Phase I/II | NCT00833781 | (Kowalski et al. 2019) |
| Changhai Hospital Stemirna Therapeutics |
Solid tumor malignancies or lymphoma; Advanced Esophageal Squamous Carcinoma; Gastric Adenocarcinoma; Pancreatic Adenocarcinoma; Colorectal Adenocarcinoma |
Subcutaneous | – | NCT03468244 | (Kowalski et al. 2019) |
| University Hospital Tuebingen | Melanoma | Intraneural or Intradermal | Phase I/II | NCT00204516 | (Kowalski et al. 2019) |
| The Norwegian Radium Hospital | Malignant melanoma | Intradermal | Phase I/II | NCT01278940 | (Gómez-Aguado et al. 2020) |
| Oslo University Hospital | Prostate cancer | Subcutaneous or Intramuscular | Phase I/II | NCT01278914 | (Kowalski et al. 2019) |
| AlphaVax | Cytomegalovirus | Subcutaneous or Intramuscular | Phase I | NCT00439803 | (Kowalski et al. 2019) |
| AlphaVax | Influenza | Subcutaneous or Intramuscular | Phase I/II | NCT00440362; NCT00706732 | (Kowalski et al. 2019) |
| AlphaVax | HIV infection | Subcutaneous or Intramuscular | Phase I | NCT00097838; NCT00063778 | (Kowalski et al. 2019) |
| AlphaVax | Colon cancer | Subcutaneous or Intramuscular |
Phase I; Phase I/II |
NCT01890213; NCT00529984 | (Kowalski et al. 2019) |
| Duke University Medical Center | Brain cancer | Intradermal | Phase I | NCT00639639 | (Lorentzen et al. 2022) |
| Duke University Medical Center | Glioblastoma | – | Phase I | NCT02529072 | (Hajj & Whitehead 2017) |
| Affiliated Hospital to Academy of Military Medical Sciences (China) | Oesophagus cancer | – | Phase I/II | NCT02693236 | (Hajj & Whitehead 2017) |
| Affiliated Hospital to Academy of Military Medical Sciences (China) | NSCLC with bone metastases | – | Phase I/II | NCT02688686 | (Hajj & Whitehead 2017) |
| Radboud University | Haematological malignancies | Intravenous | Phase I/II | NCT02528682 | (Hajj & Whitehead 2017) |
| Radboud University | Cancer immunotherapy | Intranodal | Phase IIa | NCT02692976 | (Hajj & Whitehead 2017) |
| University Hospital, Antwerp | Acute myeloid leukaemia | Intrdermal | Phase II | NCT01686334 | (Lorentzen et al. 2022) |
| University Hospital, Antwerp | Malignant pleural mesothelioma | Intradermal | Phase I/II | NCT02649829 | (Lorentzen et al. 2022) |
| Oslo University Hospital | Prostate cancer | Intradermal | Phase I/II | NCT01197625 | (Lorentzen et al. 2022) |
| Universitair Ziekenhuis Brussels | Malignant melanoma | Intradermal and Intravenous | Phase II | NCT01676779 | (Wang et al. 2022) |
| University of Florida | Glioblastoma | Intradermal | Phase II | NCT02465268 | (Hajj & Whitehead 2017) |
| Guangdong 999 Brain Hospital | Glioblastoma | Intradermal and Intravenous | Phase I/II | NCT02709616 | (Hajj & Whitehead 2017) |
| Guangdong 999 Brain Hospital | Glioblastoma | – | Phase I/II | NCT02808364 | (Wang et al. 2022) |
| Guangdong 999 Brain Hospital | Brain metastases | – | Phase I/II | NCT02808416 | (Hajj & Whitehead 2017) |
| National University, Singapore | B cell chronic lymphocytic leukaemia and NHL | – | Phase I/II | NCT02315118 | (Hajj & Whitehead 2017) |
| University of Pennsylvania | Malignant pleural mesothelioma | Intratumoral | Phase I | NCT01355965 | (Hajj & Whitehead 2017) |
| University of Pennsylvania | HIV infection | Intravenous | Phase I | NCT02388594 | (Hajj & Whitehead 2017) |
| Erasmus Medical Center | HIV infection | – | Phase IIa | NCT02888756 | (Hajj & Whitehead 2017) |
| CureVac | NSCLC | Intradermal | Phase I | NCT01915524 | (Gómez-Aguado et al. 2020) |
| Stemirna Therapeutics | Esophageal Cancer and NSCLC | Subcutaneous | – | NCT03908671 | (Gómez-Aguado et al. 2020) |
| University Hospital Tuebingen | Melanoma | Intradermal | Phase I/II | NCT00204607 | (Gómez-Aguado et al. 2020) |
| Universitair Ziekenhuis Brussel | Malignant Melanoma III and IV | Intravenous | Phase II | NCT01302496 | (Gómez-Aguado et al. 2020) |
| Universitair Ziekenhuis Brussel | Melanoma | Intradermal and Intravenous | Phase I | NCT01066390 | (Gómez-Aguado et al. 2020) |
| Radboud University | Melanoma | Intranodal | Phase I/II | NCT01530698 | (Gómez-Aguado et al. 2020) |
| Radboud University Medical Centre | Metastatic Malignant Melanoma | Intradermal and Intravenous | Phase I/II | NCT00243529 | (Gómez-Aguado et al. 2020) |
| Oslo University Hospital | Uveal Melanoma | Intradermal or Intravenous | Phase I/II | NCT00961844 | (Gómez-Aguado et al. 2020) |
| University Hospital Antwerp | Acute Myeloid Leukemia (AML) | Intradermal | Phase I | NCT00834002 | (Gómez-Aguado et al. 2020) |
| M.D. Anderson Cancer Center | AML | Intradermal | Phase I | NCT00514189 | (Gómez-Aguado et al. 2020) |
| Ludwig-Maximilians – University of Munich | AML | Intradermal | Phase I/II | NCT01734304 | (Gómez-Aguado et al. 2020) |
| University of Pennsylvania | Relapsed or Refractory AML | Intravenous | Early Phase I | NCT02623582 | (Gómez-Aguado et al. 2020) |
| CureVac | Prostate cancer | Intradermal | Phase I/II | NCT01817738 | (Gómez-Aguado et al. 2020) |
| University of Florida | Prostate Cancer | Intradermal | Phase I/II (withdrawn) | NCT01153113 | (Gómez-Aguado et al. 2020) |
| Oslo University Hospital | Glioblastoma | Intradermal | Phase II/III | NCT03548571 | (Gómez-Aguado et al. 2020) |
| Oslo University Hospital | Recurrent Epithelial Ovarian Cancer | Intradermal | Phase I/II | NCT01334047 | (Gómez-Aguado et al. 2020) |
| University of Pennsylvania | Breast Cancer | Intratumoral | Phase I | NCT01837602 | (Gómez-Aguado et al. 2020) |
| Universitair Ziekenhuis Brussel | Early Breast Cancer | Intratumoral | Phase I | NCT03788083 | (Gómez-Aguado et al. 2020) |
| University of Pennsylvania | Hodgkin Lymphoma | Intravenous | Early Phase I | NCT02277522; NCT02624258 | (Gómez-Aguado et al. 2020) |
| University of Pennsylvania | Metastatic Pancreatic Ductal Adenocarcinoma | Intravenous | Phase I | NCT01897415 | (Gómez-Aguado et al. 2020) |
| University of Pennsylvania | Malignant Melanoma, Breast Cancer | Intravenous | Early Phase I | NCT03060356 | (Gómez-Aguado et al. 2020) |
| Antwerp University Hospital, Hematology | Glioblastoma; Renal Cell Carcinoma; Sarcomas; Breast Cancers; Malignant Mesothelioma; Colorectal Tumor | Intradermal | Phase I | NCT01291420 | (Gómez-Aguado et al. 2020) |
| AstraZeneca | Heart Failure | Epicardial injection | Phase II | NCT03370887 | (Gómez-Aguado et al. 2020) |
| AstraZeneca | Ulcers associated with type II diabetes | Intradermal | Phase I | NCT02935712 | (Gómez-Aguado et al. 2020) |
| University of Pennsylvania | HIV infection | Intravenous | Phase I | NCT03617198 | (Gómez-Aguado et al. 2020) |
| Sangamo Therapeutics | HIV infection | Intravenous |
Phase I; Phase I/II |
NCT02225665; NCT04201782 | (Gómez-Aguado et al. 2020) |
|
City of Hope Medical Center; Sangamo Therapeutics; California Institute for Regenerative Medicine (CIRM) |
HIV infection | Intravenous | Phase I | NCT02500849 | (Gómez-Aguado et al. 2020) |
| Bioverativ, (Sanofi) | Sickle Cell Disease | Intravenous | Phase I/II | NCT03653247 | (Gómez-Aguado et al. 2020) |
| Institut de Recherches Internationales Servier | B acute lymphoblastic leukemia | Intravenous | Phase I | NCT02808442; NCT02746952; NCT02735083 | (Gómez-Aguado et al. 2020) |
| Chinese PLA General Hospital | B cell leukemia and B cell lymphoma | Intravenous | Phase I/II | NCT03166878 | (Gómez-Aguado et al. 2020) |
| Moderna | Zika Virus | – | Phase I | NCT04064905 | (Gómez-Aguado et al. 2020) |
| GlaxoSmithKline | Tuberculosis | Intramuscular | Phase II | NCT01669096 | (Gómez-Aguado et al. 2020) |