Ignite Creation Date:
2024-05-06 @ 2:27 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04324996
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-03-25
Brief Title:
A Phase III Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19
Sponsor:
Chongqing Public Health Medical Center
Organization:
Chongqing Public Health Medical Center
Study Overview
Official Title:
A Phase III Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells Secreting IL15 Superagonist and GM-CSF-neutralizing scFv for Therapy of COVID-19
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SARS-CoV-2 infection mainly leads to interstitial pneumonia The patients with low immunity have more serious conditions At present there is no specific drugtherapy available for COVID-19 NK cells are the major cells of the natural immune system which are essential for innate immunity and adaptive immunity and are indispensable in the defense of virus infection NKG2D is an activating receptor of NK cells which can recognize and thus clear virus infected cells NK cells modified by CAR play a role in targeted cell therapy and have benn demonstrated very safe without severe side effects such as cytokine releasing syndromes The survival time of NK cells will be very short if there is no IL-15-sustained support after adoptive transfer into the body In comparison with natural IL-15 in vivo IL-15 superagonist sIL-15IL-15RÉ‘ chimeric protein has increased the activity by nearly 20 times and as well as improved pharmacokinetic characteristics with longer persistence and enhanced target cytotoxicity CAR-T cell-mediated cytokine release syndrome CRS and neurotoxicity have been shown to be abrogated through GM-CSF neutralization ACE2 is the receptor of SARS-CoV-2 and binds to S protein of the virus envelope We have constructed and prepared the universal off-the-shelf IL15 superagonist- and GM-CSF neutralizing scFv-secreting NKG2D-ACE2 CAR-NK derived from cord blood By targeting the S protein of SARS-CoV-2 and NKG2DL on the surface of infected cells with ACE2 and NKG2D respectively and with the strong synergistic effect of IL15 superagonist and CRS prevention through GM-CSF neutralizing scFv we hope that the SARS-CoV-2 virus particles and their infected cells can be safely and effectively removed thus providing a safe and effective cell therapy for COVID-19 In addition ACE2 CAR-NK cells can competitively inhibit SARS-CoV-2 infection of type II alveolar epithelial cells and other important organ or tissue cells through ACE2 so as to make SARS-CoV-2 abortive infection ie no production of infectious virus particles
This project is an open randomized parallel multicenter phase III clinical trial The NKG2D-ACE2 CAR-NK cells secreting super IL15 superagonist and GM-CSF neutralizing scFv are going to be give by intravenous infusion 108 cells per kilogram of body weight once a week for the treatment of 30 patients with each common severe and critical type COVID-19 respectively
This project is an open randomized parallel multicenter phase III clinical trial The NKG2D-ACE2 CAR-NK cells secreting super IL15 superagonist and GM-CSF neutralizing scFv are going to be give by intravenous infusion 108 cells per kilogram of body weight once a week for the treatment of 30 patients with each common severe and critical type COVID-19 respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None