Off-the-shelf NK Cells (KDS-1000) as Immunotherapy for COVID-19

NCT04797975 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: KNK-COV-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is hypothesized that immunotherapy with off-the-shelf NK cells (KDS-1000) early in the course of COVID-19 disease is safe and may augment innate immunity, thereby limiting disease progression and improving survival.

Conditions

Covid19

Keywords

Cell Therapy; COVID-19; Natural Killer Cells; NK Cells; Off-the-shelf

Outcome Measures

Primary Outcomes (1)

• Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of adverse events (AE)

  Rate and severity of AE.

  28 Days

Secondary Outcomes (3)

• Determine the efficacy KDS-1000 given at low and high doses compared to placebo by COVID-19 specific questionnaire.

  90 Days

• Determine the efficacy KDS-1000 given at low and high doses compared to placebo by measurement of SARS-CoV-2 clearance.

  28 days

• Determine the safety of KDS-1000 given at low and high doses compared to placebo by collecting the rate and severity of AE.

  90 Days

Study Arms (2)

KDS-1000

EXPERIMENTAL

NK cells expanded ex vivo using PM21 membrane particles:

Biological: KDS-1000

Control

PLACEBO COMPARATOR

0.9% Normal Saline

Other: Placebo

Interventions

KDS-1000 BIOLOGICAL

Non-randomized part of study: * At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals. Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts): * Cohort 1: Low Dose, 2x10E8 cells/dose * Cohort 2: High Dose, 1x10E9 cells/dose

KDS-1000

Placebo OTHER

0.9% Normal Saline

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are 18-70 years of age;
• Patients must have at least one of the following risk factors for developing severe COVID-19 disease:
• Age 50 to 70 years;
• Obesity (body mass index (BMI) of 30 or greater);
• Hypertension;
• Current smoker;
• Diabetes mellitus (Type 1 or type 2);
• Stable cardiac disease.
• Experiencing symptoms of mild to moderate COVID-19 not requiring supplemental oxygen;
• Having confirmed infection with SARS-CoV-2, defined as detection of SARS-CoV-2 from nasopharyngeal swab or lower respiratory tract specimen;
• Karnofsky Performance Score ≥70%;
• Enrolled within the first 4 days of onset of symptoms;
• Able and willing to comply with the protocol for duration of the study, including 24 hour hospitalization for study drug administration and monitoring, and compliance with follow-up visit schedule;
• Signed IRB approved informed consent.

You may not qualify if:

• Patient is at high-risk for severe COVID-19 due to co-morbidities defined as:
• Underlying lung disease such as emphysema, chronic lung disease, COPD, asthma, chronic bronchiectasis or respiratory failure requiring baseline oxygen (O2) support;
• Immunocompromised host status due to cancer, transplant, or other causes of immunodeficiency;
• Immunosuppressive therapy, including but not limited to the following:
• Corticosteroids (except topical corticosteroids);
• Interleukin (IL)-6 or Tumor necrosis factor alpha (TNFα) blockade;
• Other immunotherapies.
• Patient with the following signs of abnormal organ or bone marrow function as defined below:
• AST(SGOT) and/or ALT(SGPT) \> 3 x upper limit of normal (ULN);
• Serum (total) bilirubin \> 1.5 x ULN;
• Creatinine Clearance ≤ 30 mL/min (by Modification of Diet in Renal Disease (MDRD) formula);
• Hemoglobin \< 9 g/dL;
• Thrombocytes ≤ 75.000/uL;
• Absolute neutrophil count (ANC) ≤ 1.500/uL;
• Prothrombin time (PT) or activated partial thromboplastin (aPTT) time \>1.5 × ULN;

Sponsors & Collaborators

• Kiadis Pharma: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 15, 2021
• Study Start: December 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share