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Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04351659
Enrollment
8
Registered
2020-04-17
Start date
2020-04-14
Completion date
2022-09-30
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

SARS-CoV-2, Coronavirus disease

Brief summary

The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously for the treatment of severe SARS-CoV-2 infections.

Detailed description

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine or specific treatment has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients. The aim of this protocol is to demonstrate the feasibility of preparing SARS-CoV-2 specific T cells from convalescent donors for urgent clinical use. The specific hypothesis is that SARS-CoV-2 specific T cells can be isolated from the blood of convalescent donors rapidly and efficiently using SARS-CoV-2 specific peptides and an automated medical device for emergent treatment of severe COVID-19 disease. A minimum of 8 convalescent donors will be recruited from Singapore to attain HLA sharing with at least 90% of the general population.

Interventions

OTHERBlood donation from convalescent donor

Donation of 1 unit of blood or leukapheresis

Sponsors

Singapore General Hospital
CollaboratorOTHER
National University Hospital, Singapore
CollaboratorOTHER
KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Age 21 to 65 * Had a history of COVID-19 with documented positive test for SARS-CoV-2 in the past * Has recovered from COVID-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria * Negative test for SARS-CoV-2 currently

Exclusion criteria

* Do not meet the standard criteria for blood cell donation at National University Hospital or Singapore General Hospital.

Design outcomes

Primary

MeasureTime frameDescription
Success rate in production of SARS-CoV-2 specific T cells from convalescent donorTwo weeks (The expected duration of donor participation is 2 weeks)Success of SARS-CoV-2 specific T cell manufacturing is defined as production of \>200,000 T cells per donor. The success rate will be summarized descriptively.

Countries

Singapore

Contacts

Primary ContactMichaela Seng
childhoodcancer@kkh.com.sg82487085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026