Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19

Summary

This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.

Conditions

• Coronavirus
• Coronavirus Infection
• Severe Acute Respiratory Syndrome Coronavirus 2
• Pneumonia
• Pneumonia, Viral
• Lung Diseases
• Respiratory Tract Disease
• Respiratory Tract Infections
• Coronaviridae Infections
• Nidovirales Infections
• RNA Virus Infections
• Virus Disease
• Immunologic Disease
• ARDS
• Immunologic Factors
• Physiological Effects of Drugs
• Antiviral Agents
• Anti-infective Agents
• Analgesics
• Antimetabolites, Antineoplastic

Interventions

BIOLOGICAL

CYNK-001

CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.

Sponsors & Collaborators

• Access to Advanced Health Institute (AAHI)

  collaborator OTHER

• Lung Biotechnology PBC

  collaborator INDUSTRY

• California Institute for Regenerative Medicine (CIRM)

  collaborator OTHER

• Celularity Incorporated

  lead INDUSTRY

Principal Investigators

• Corey Casper, MD MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-13

Primary Completion

2021-12-30

Completion

2022-06-30

FDA Drug

Yes

Countries

• United States

Study Locations