Grant Award Details

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 Number: 
CLIN2COVID19-11857
Project Objective: 
  • Primary objective of this Phase I/II clinical study is to evaluate the safety, tolerability and efficacy of human placental hematopoietic stem cell derived NK cells (CYNK-001) in the treatment of adults with COVID-19
Investigator: 
Institution: 
Type: 
PI
Disease Focus: 
COVID-19
Infectious Disease
Respiratory Disorders
Human Stem Cell Use: 
Adult Stem Cell
Award Value: 
$750,000
Status: 
Pre-Active

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

  • 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.