A phase I/II study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) for the treatment of adults with COVID-19
Grant Award Details
Grant Type:
Grant Number:
CLIN2COVID19-11857
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$315,000
Status:
Closed
Progress Reports
Reporting Period:
Final Operational Milestone #2
Grant Application Details
Application Title:
A phase I/II study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) for the treatment of adults with COVID-19
Public Abstract:
Therapeutic Candidate or Device
Human placental hematopoietic stem cell derived natural killer cells (CYNK-001)
Indication
SARS-CoV-2 positive patients requiring hospital admission and have any 2 out of 3 symptoms: fever, cough, or positive disease-related chest x-ray.
Therapeutic Mechanism
CYNK-001 is allogenic, human placental hematopoietic stem cell-derived NK cells that express the dominant NK cells marker CD56 and lack lineage markers such as CD3, and CD19. CYNK-001 demonstrates a range of biological activities expected of NK cells, it can recognize and kill the stressed and/or virus-infected cells. With demonstrated safety data from in vivo and clinical study, it is concluded that CYNK-001 is the potential cellular therapy for COVID-19 treatment.
Unmet Medical Need
The primary objectives of the Phase I study is to evaluate the safety, tolerability, and efficacy of CYNK-001 in COVID-19. The co-primary endpoints of Phase II study: A) To determine virologic efficacy of CYNK-001 in COVID-19 by rRT-PCR. B) To assess the impact of CYNK-001 on clinical symptoms.
Project Objective
Complete enrolling 86 patient for phase I/II study
Major Proposed Activities
Human placental hematopoietic stem cell derived natural killer cells (CYNK-001)
Indication
SARS-CoV-2 positive patients requiring hospital admission and have any 2 out of 3 symptoms: fever, cough, or positive disease-related chest x-ray.
Therapeutic Mechanism
CYNK-001 is allogenic, human placental hematopoietic stem cell-derived NK cells that express the dominant NK cells marker CD56 and lack lineage markers such as CD3, and CD19. CYNK-001 demonstrates a range of biological activities expected of NK cells, it can recognize and kill the stressed and/or virus-infected cells. With demonstrated safety data from in vivo and clinical study, it is concluded that CYNK-001 is the potential cellular therapy for COVID-19 treatment.
Unmet Medical Need
The primary objectives of the Phase I study is to evaluate the safety, tolerability, and efficacy of CYNK-001 in COVID-19. The co-primary endpoints of Phase II study: A) To determine virologic efficacy of CYNK-001 in COVID-19 by rRT-PCR. B) To assess the impact of CYNK-001 on clinical symptoms.
Project Objective
Complete enrolling 86 patient for phase I/II study
Major Proposed Activities
- Complete phase I study for 14 COVID-19 patients enrollment
- Complete phase II study for 72 COVID-19 patients enrollment
- Clinical data record, collection and management
Statement of Benefit to California:
Provide potential stem cell based cellular therapeutic treatment for pandemic COVID-19, which will benefit not only for the State of California and its citizens, but for the people worldwide.