Status:
UNKNOWN
A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19
Lead Sponsor:
Chongqing Public Health Medical Center
Collaborating Sponsors:
Chongqing Sidemu Biotech
Zhejiang Qixin Biotech
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 drug/therapy available for COVID-19. NK cells...
Eligibility Criteria
Inclusion
- Sign written informed consent;
- Age ≥18 years;
- Conforms to the NCP Critical and Critical Diagnostic Standards, namely "Pneumonitis Diagnosis and Treatment Scheme for New Coronavirus Infection (Trial Version 6)". Comprehensive judgment based on epidemiological history, clinical manifestations and etiological examination;
- The course of disease is within 14 days after the onset of illness;
- Willing to collect nasopharyngeal or oropharyngeal swabs before administration.
Exclusion
- Patients participating in clinical trials of other drugs;
- pregnant or lactating women;
- ALT / AST\> 5 times ULN, or neutrophils \<0.5 \* 109 / L, or platelets less than 50 \* 109 / L;
- Expected survival time is less than 1 week;
- A clear diagnosis of rheumatism-related diseases;
- Long-term oral anti-rejection drugs or immunomodulatory drugs;
- Patients hypersensitive to NK cells and their preservation solution.
Key Trial Info
Start Date :
February 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04324996
Start Date
February 21 2020
End Date
August 31 2022
Last Update
November 17 2020
Active Locations (1)
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1
Chongqing Public Health Medical Center
Chongqing, China, 400036