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.
This Phase 1/2 study evaluated the safety and potential efficacy of CYNK-001, an allogeneic natural killer (NK) cell therapy derived from human placental CD34+ cells, in adult patients with moderate COVID-19. Participants received intravenous infusions of CYNK-001 on Days 1, 4, and 7. CYNK-001 IV infusions administered at an initial desensitizing dose of 150 × 106 cells on Day 1 followed by a dose of 600 × 106 cells on Days 4 and 7 plus best supportive care. The study was designed to include a Phase 1 dose-escalation portion followed by a randomized Phase 2 portion; however, due to early termination, only Phase 1 participants were enrolled and treated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
UC Irvine
Irvine, California, United States
Atlantic Health
Morristown, New Jersey, United States
Atlantic Health
Summit, New Jersey, United States
Multicare Health System
Tacoma, Washington, United States
Phase 1: Frequency and Severity of Adverse Events (AE)
Number and severity of treatment-emergent adverse events (TEAEs), assessed according to CTCAE version 5.0. TEAEs were defined as adverse events that started or worsened on or after the first dose of study treatment.
Time frame: From first dose through 28 days after first dose, up to 6 months
All-cause Mortality
Number of participants who died from any cause during the study period.
Time frame: From first dose through 28 days after first dose, up to 6 months
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