Trial Outcomes & Findings for Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 (NCT NCT04365101)

Last Updated: 2026-06-01

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

From first dose through 28 days after first dose, up to 6 months

Results posted on

2026-06-01

Participant Flow

A total of 8 subjects were screened, of whom 7 were enrolled and received at least one dose of study treatment. One screened subject was not enrolled due to screen failure.

Assessed for eligibility: 8 Excluded: 1 Not meeting inclusion/exclusion criteria: 1 Due to early study termination, only 7 participants were enrolled in Phase 1. No participants were enrolled in Phase 2.

Participant milestones

Participant milestones
Measure	Phase I CYNK-001 infusions 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. CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I CYNK-001 infusions 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. CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I n=7 Participants CYNK-001 infusions on Days 1, 4, and 7 CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Age, Continuous	52 years n=24 Participants
Sex: Female, Male Female	3 Participants n=24 Participants
Sex: Female, Male Male	4 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants
Race (NIH/OMB) Asian	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=24 Participants
Race (NIH/OMB) White	4 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=24 Participants
Region of Enrollment United States	7 participants n=24 Participants

PRIMARY outcome

Timeframe: From first dose through 28 days after first dose, up to 6 months

Population: Safety population (all participants who received at least one dose of study treatment).

Outcome measures

Outcome measures
Measure	Phase I n=7 Participants CYNK-001 infusions on Days 1, 4, and 7 CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Phase 1: Frequency and Severity of Adverse Events (AE)	6 participants

SECONDARY outcome

Timeframe: From first dose through 28 days after first dose, up to 6 months

Population: Safety population (all participants who received at least one dose of study treatment).

Number of participants who died from any cause during the study period.

Outcome measures

Outcome measures
Measure	Phase I n=7 Participants CYNK-001 infusions on Days 1, 4, and 7 CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
All-cause Mortality	1 participants

Adverse Events

Phase I

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase I n=7 participants at risk CYNK-001 infusions on Days 1, 4, and 7 CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Respiratory, thoracic and mediastinal disorders Respiratory failure	14.3% 1/7 • from first dose through 28 days after first dose, up to 6 months Adverse events were coded using MedDRA version 23.0. Treatment-emergent adverse events (TEAEs) were defined as events that started or worsened on or after the first dose of study treatment. Subjects are counted once per preferred term. Adverse events were graded according to CTCAE version 5.0.
Respiratory, thoracic and mediastinal disorders orthostatic hypotension	14.3% 1/7 • from first dose through 28 days after first dose, up to 6 months Adverse events were coded using MedDRA version 23.0. Treatment-emergent adverse events (TEAEs) were defined as events that started or worsened on or after the first dose of study treatment. Subjects are counted once per preferred term. Adverse events were graded according to CTCAE version 5.0.

Other adverse events

Other adverse events
Measure	Phase I n=7 participants at risk CYNK-001 infusions on Days 1, 4, and 7 CYNK-001: CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Nervous system disorders Headache	14.3% 1/7 • from first dose through 28 days after first dose, up to 6 months Adverse events were coded using MedDRA version 23.0. Treatment-emergent adverse events (TEAEs) were defined as events that started or worsened on or after the first dose of study treatment. Subjects are counted once per preferred term. Adverse events were graded according to CTCAE version 5.0.
Nervous system disorders Dizziness	14.3% 1/7 • from first dose through 28 days after first dose, up to 6 months Adverse events were coded using MedDRA version 23.0. Treatment-emergent adverse events (TEAEs) were defined as events that started or worsened on or after the first dose of study treatment. Subjects are counted once per preferred term. Adverse events were graded according to CTCAE version 5.0.
Vascular disorders hypotension	28.6% 2/7 • from first dose through 28 days after first dose, up to 6 months Adverse events were coded using MedDRA version 23.0. Treatment-emergent adverse events (TEAEs) were defined as events that started or worsened on or after the first dose of study treatment. Subjects are counted once per preferred term. Adverse events were graded according to CTCAE version 5.0.

Additional Information

Sharmila Koppisetti, MD

celularity Inc

Phone: 973-768-2170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place