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Table 1 Overview of ongoing mRNA-based drug’s clinical trials

From: mRNA-based vaccines and therapeutics: an in-depth survey of current and upcoming clinical applications

Trial number

Delivery system/route

mRNA encoding

Product name

Disease/virus

Phase

Start date (MM/YYYY)

COVID-19

      

 NCT04776317

SAM-LNP, i.m

SARS-CoV-2 spike

NR

COVID-19

I

03/2021

 NCT04805125

LNP, i.m

SARS-CoV-2 spike

mRNA-1273

COVID-19

III

04/2021

 NCT04824638

LNP, i.m

SARS-CoV-2 spike

BNT162b2

COVID-19

II

03/2021

 NCT04900467

LNP, i.m

SARS-CoV-2 spike

BNT162b2/mRNA-1273

COVID-19

NR

05/2021

 NCT04961229

LNP, i.m

SARS-CoV-2 spike

BNT162b2

COVID-19

IV

10/2021

 NCT05124171

LNP, i.m

SARS-CoV-2 spike

BNT162b2

COVID-19

III

12/2021

 NCT05428592

LNP, i.m

SARS-CoV-2 spike

LVRNA009

COVID-19

III

04/2023

 NCT05549206

LNP, i.m

SARS-CoV-2 spike (Omicron BA.5)

LVRNA012

COVID-19

NR

04/2023

 NCT05599802

LNP, i.m

SARS-CoV-2 spike variant

LVRNA010

COVID-19

I

02/2023

 NCT05602961

LNP, i.m

SARS-CoV-2 spike

GLB-COV2-043

COVID-19

I/II

02/2023

 NCT05609045

LNP, i.m

SARS-CoV-2 Omicron variant

RH109

COVID-19

I

06/2023

 NCT05658523

LNP, i.m

SARS-CoV-2 spike

Moderna/Novavax

COVID-19

III

02/2023

 NCT05672355

MVA, i.m

SARS-CoV-2 spike

GEO-CM04S1

COVID-19

II

09/2023

 NCT05682638

LNP, i.m

SARS-CoV-2 spike

LVRNA009

COVID-19

III

01/2023

 NCT05743335

LNP, i.m

SARS-CoV-2 spike

JCXH-221

COVID-19

I/II

03/2023

 NCT05745545

LNP, i.m

SARS-CoV-2 spike (Omicron BA.5)

NR

COVID-19

NR

02/2023

 NCT05749926

LNP, i.m

SARS-CoV-2 spike (Omicron BA.5)

BNT162b2/Sanofi

COVID-19

III

05/2023

 NCT05788185

LNP, i.m

SARS-CoV-2 spike

RVM-V001/RVM-V002

COVID-19

I/II

03/2023

 NCT05812014

LNP, i.m

SARS-CoV-2 spike

LVRNA021

COVID-19

III

03/2023

 NCT05815498

LNP, i.m

SARS-CoV-2 spike

mRNA-1283.222

COVID-19

III

03/2023

 NCT05827926

LNP, i.m

SARS-CoV-2 spike + HA

mRNA-1083

COVID-19/Influenza

I/II

04/2023

 NCT05875701

LNP, i.m

SARS-CoV-2 spike

Novavax

COVID-19

III

03/2023

 NCT05907044

LNP, i.m

SARS-CoV-2 spike (Alpha, Beta + Omicron XBB.1.5/Alpha, Beta + Omicron BA.2, 4, 5)

RQ3027/RQ3025

COVID-19

NR

05/2023

 NCT05911087

LNP, i.m

SARS-CoV-2 spike

SWIM816

COVID-19

II/III

06/2023

Cancer

      

 mRNA-based vaccine

      

  NCT03897881

LNP, i.m

Neoantigen

mRNA-4157

Stage III/IV melanoma

IIb

07/2019

  NCT03908671

LNP, s.c

Neoantigen

PCV

EC/NSCLC

I

10/2019

  NCT04161755

LNP, i.v

Neoantigen

PCV

PC

I

12/2019

  NCT04382898

LNP, i.v

4 cancer antigens

BNT112

mCRPC/LPC

II

12/2019

  NCT04683939

LNP, i.v

CLDN18.2

BNT141

GC/PC/OC/BTC

II

01/2022

  NCT05761717

LNP, s.c

Personalised cancer antigen

NR

Postoperative HC

NR

04/2023

  NCT05738447

LNP, i.m

HBsAg

HBV vaccine

HC

I

02/2023

 mRNA-based cell therapy

     

  NCT01197625

i.v

hTERT/Survivin

DC vaccine

PrCa

II

09/2010

  NCT04503278

RNA-LPX, i.v

CLDN6

BNT211

Advanced solid tumors

I/IIa

09/2020

  NCT04981691

i.v

MESO

Amaretto

Refractory malignant solid neoplasm

I

10/2021

  NCT04984356

i.v

CD7

WU-CART-007

T-ALL/LBL

I/II

01/2022

 RiboMab (bispecific monoclonal antibody (mAb)-encoding mRNA)

  NCT04683939

LNP, i.m

CLDN18.2

BNT141

Multiple solid tumors

I/IIa

01/2022

Infectious disease

      

 NCT04917861

LNP, i.m.

Zika

mRNA-1893

Flavivirus

II

06/2021

 NCT05085366

LNP, i.m.

gB

mRNA-1647

CMV

III

10/2021

 NCT05127434

LNP, i.m.

preF glycoprotein

mRNA-1345

RSV-LRTD

II/III

11/2021

 NCT05164094

LNP, i.m.

EBV gB (gB/gH/gL/gp42/gB350)

mRNA-1189

EBV

I

12/2021

 NCT05217641

LNP, i.m.

BG505 MD39.3/BG505 MD39.3 gp151/BG505 MD39.3 gp151 CD4KO

mRNA -1574

HIV

I

02/2022

 NCT05398796

LNP, i.m.

pre-F/G

mRNA -1215

Nipah virus

I

07/2022

 NCT05414786

LNP, i.p.

eOD-GT8 60mer

mRNA-1644

AIDS

I

05/2022

 NCT05415462

LNP, i.m.

HA

mRNA-1010

Seasonal influenza

III

06/2022

 NCT05683457

LNP, i.m.

gB

mRNA-1647 

CMV

II

04/2023

 NCT05701800

LNP, i.m.

zoster virus envelope glycoprotein E

mRNA-1468

Herpes zoster

I/II

01/2023

 NCT05743881

LNP, i.m.

preF glycoprotein

mRNA-1345/mRNA-1365

RSV-LRTD

I

02/2023

 NCT05755620

LNP, i.m.

HA

H1ssF-3928

Influenza

I

04/2023

 NCT05823974

LNP, i.m.

NR

GSK4382276A

Influenza

I/II

04/2023

 NCT05827068

LNP, i.m.

HA

mRNA-1011.1/mRNA-1011.2/mRNA-1012.1

Seasonal influenza

I/II

03/2023

 NCT05827978

LNP, i.m.

HA

mRNA-1010

Seasonal influenza

III

04/2023

 NCT05829356

LNP, i.m.

Full-length HA sequence of A/Tasmania/503/2020 (H3N2)

NR

Influenza

I

04/2023

 NCT05831111

LNP, i.m.

EBV gB

mRNA-1195

EBV

I

04/2023

 NCT05868382

LNP, i.m.

HA

mRNA-1010 candidate variations

Influenza

II

05/2023

 NCT05905731

i.v.

HBV-TCR

NR

CHB

I

06/2023

Protein replacement

      

 NCT04442347

LNP, i.v.

OTC

ARCT-810

OTCD

Ib

 

Gene editing

      

 In vivo

      

  NCT04601051

LNP, i.v.

TTR-targeted CRISPR-Cas9

NTLA-2001

ATTRv-PN/ATTR-CM

I

11/2020

 Ex vivo

      

  NCT03655678

i.v.

BCL11A-targeted gRNA

CTX001

TDT

III

09/2018

  NCT04426669

i.v.

CISH-targeted CRISPR-Cas9

NR

GI cancer

I/II

05/2020

  NCT05456880

i.v.

HBG1/2 promoter-targeted CRISPR-Cas9

BEAM-101

SCD

I/II

08/2022

  1. AIDS acquired immunodeficiency syndrome, ATTR-CM transthyretin amyloidosis-related cardiomyopathy, ATTRv-PN hereditary transthyretin amyloidosis with polyneuropathy, BTC biliary tract cancer, CHB chronic hepatitis B, CISH cytokine-induced SH2 protein, CLDN18.2 claudin-18.2, CML chronic myeloid leukemia, CMV cytomegalovirus, EC esophageal cancer, EBV epstein-barr virus, gB Glycoprotein B, GC gastric cancer, GI gastro-intestinal, HA hemagglutinin, HBsAg hepatitis B surface antigen, HBV-TCR hepatitis-B virus-antigen-specific T cell receptor, HC hepatocellular carcinoma, HIV human immunodeficiency virus, i.m. intramuscular, i.p. intraperitoneal, i.v. intravenous, LBL Lymphoblastic Lymphoma, LPC localized prostate cancer, mCRPC metastatic castration resistant prostate cancer, MESO mesothelin, MVA modified vaccinia virus Ankara, NR Not reported, NSCLC nonsmall cell lung cancer, OC ovarian cancer, OTC ornithine transcarbamylase, OTCD ornithine transcarbamylase deficiency disease, PC pancreatic cancer, PrCa prostate cancer, pre-F/G secreted prefusion stabilized F component covalently linked to G monomer, RSV-LRTD respiratory syncytial virus-associated lower respiratory tract disease, SAM-LNP self-amplifying mRNA-lipid nanoparticles, S.C. subcutaneous injection, SCD sickle cell disease, T-ALL T-cell acute lymphoblastic leukemia, TDT transfusion-dependent β-thalassemia, TTR transthyretin
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Journal of Biomedical Science

ISSN: 1423-0127