Phase 1/2A clinical study of descartes-30 in acute respiratory distress syndrome
Ended Project Grant Awarded Last action
- Award ID
- R44HL158446
- Recipient
-
Cartesian Therapeutics Inc. UEI PXGLS86SY6B1
- Awarding agency
-
National Heart Lung and Blood Institute
National Institutes of Health, Department of Health and Human Services
- Obligated
- $5,993,950
Award facts
- Assistance listing
- 93.837 Cardiovascular Diseases Research
- Completion date
- Originally
- Funding
-
- $4,995,208.00 Federal
- $998,742.00 Non-federal
- Place of performance
- Gaithersburg, MD 20878, USA
Award details come from USAspending.gov.
Description
- Abstract
- This application is to support a clinical trial of the first mrna engineered cell therapy for acute respiratory distress syndrome (ards), including ards caused by covid-19. The FDA has already reviewed the IND application and determined that the study may proceed. Ards is a severe inflammatory respiratory failure that kills an estimated 80,000 americans each year. 80% of ards patients require mechanical ventilation. No FDA-approved therapies for ards are available. Ards may result from infectious or non-infectious (e.g., traumatic or chemical) insults. Covid-19 is currently the most common cause of ards, and the vast majority of covid-19 deaths are due to ards. Neutrophil extracellular traps (nets) drive the hyperactive inflammatory response in ards and covid-19, and presence of nets correlates strongly with ards severity. Nets are produced by locally-trafficked neutrophils undergoing netosis, a programmed cell death where the cells lyse to secrete DNA decorated with inflammatory proteins. Low amounts of nets are thought to help entrap infection, but hyperactivated neutrophils produce large quantities of nets that cause hypoxia and immune thrombi due to physical blockade of alveoli and microvasculature. A net-degrading therapy therefore would be a significant advance in treatment of ards. Descartes-30 is the first allogeneic (i.e., off-the-shelf) engineered human mesenchymal stem cell (MSC) therapy secreting a combination of two potent net-degrading enzymes. In this phase 1/2A study, the hypothesis to be tested is that descartes-30 will be well tolerated and show evidence of efficacy in patients with moderate to severe ards and covid- 19. Aims are to determine the maximum tolerated dose and evidence of preliminary efficacy, define pharmacokinetic properties and biologic correlates of disease, and establish a validated potency assay for use in later-stage clinical development. These data will inform the design of a controlled registration study in patients with moderate-to-severe ards.
Transactions
| Action | Federal | Non-federal | Date |
|---|---|---|---|
| Amendment | $0 | $0 | |
| Amendment | $999,491 | $0 | |
| Amendment | $999,491 | $0 | |
| Amendment | $998,742 | $0 | |
| Amendment | $998,742 | $0 | |
| Original award | $998,742 | $998,742 |
Quick answers
Who received award R44HL158446?
R44HL158446 was awarded to Cartesian Therapeutics Inc. by National Heart Lung and Blood Institute (National Institutes of Health) on May 1, 2021.
How much is award R44HL158446 worth?
$5,993,950 has been obligated on R44HL158446: $4,995,208 in federal funding and $998,742 in non-federal funding.
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