This is a Phase I/II, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of GKL-006RTU injection in participants with moderate to severe Acute Respiratory Distress Syndrome (ARDS).
The study consists of two parts:
Phase I is a single-arm, open-label study. Eligible participants will receive a single intravenous infusion of GKL-006RTU injection (1 bag or 3 bags, containing approximately 5.0±0.5×10\^8 invariant natural killer T (iNKT) cells per bag) in addition to standard background treatment. The primary objective of this phase is to assess the safety and tolerability of the investigational product.
Phase II is a randomized, double-blind, placebo-controlled study. Based on the results from Phase I, participants will receive GKL-006RTU injection or placebo via intravenous infusion, in addition to standard background treatment. The primary objective of this phase is to evaluate the efficacy of GKL-006RTU injection in treating moderate to severe ARDS.
Male or female, aged 18 to 80 years (inclusive).
Participants (or their legally authorized representatives, if the participant is unable to provide informed consent) who fully understand the nature of the study, voluntarily sign the informed consent form, and are willing to comply with and complete all study procedures during the study period.
Clinically diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to the diagnostic criteria, with a time from diagnosis to enrollment not exceeding 96 hours.
The etiology of ARDS is confirmed to be infectious.
Positive screening for infectious diseases meeting any of the following: a)Active Hepatitis B virus infection (defined as [positive Hepatitis B Surface Antigen (HBsAg) or positive Hepatitis B Core Antibody (HBcAb)] with Hepatitis B Virus DNA [HBV-DNA] above the upper limit of normal); b) Hepatitis C virus (HCV) infection (defined as positive HCV antibody with HCV-RNA above the upper limit of normal); c) Human Immunodeficiency Virus (HIV) infection (defined as positive HIV antibody); d) Syphilis infection (defined as positive Treponema pallidum antibody).
Known immune system dysfunction (e.g., primary immunodeficiency, acquired immunodeficiency) or currently receiving systemic immunosuppressive therapy.
Expected survival time of less than 72 hours.
Occurrence of a cerebrovascular or cardiovascular event (unstable angina, congestive heart failure, myocardial infarction, or stroke) within the past 6 months; or severe cardiovascular disease at screening: New York Heart Association (NYHA) Functional Classification Class III or higher; uncontrolled myocarditis or valvular disease; hemodynamic instability, severe cardiac dysfunction, malignant arrhythmias, or severe rhythm/conduction abnormalities requiring drug therapy within the past 6 months.
Parallel
GKL-006RTU injection
DrugiNKT cell injection
Placebo
DrugMatching placebo for GKL-006RTU injection
Phase I: Incidence and Severity of Adverse Events and Serious Adverse Events
To evaluate the safety and tolerability of GKL-006RTU injection in participants with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). Safety will be assessed throughout the study duration, from Day 1 to Day 180.
Phase II: Difference in Ventilator-Free Days within 28 Days Compared to Placebo
To evaluate the efficacy of GKL-006RTU injection compared to placebo in participants with moderate-to-severe ARDS. The primary efficacy endpoint is the difference in ventilator-free days (days alive and free from mechanical ventilation) within 28 days post-treatment between the GKL-006RTU injection group and the placebo group.
Phase I: All-cause Mortality at Day 1 to Day 28, Day 90, and Day 180
To assess the all-cause mortality rate in participants treated with GKL-006RTU injection at Day 1 to Day 28, Day 90, and Day 180.
Phase I: Ventilator-Free Days, ICU-Free Days, and Organ Support-Free Days within Day 1 to Day 28
To evaluate the number of days alive and free from mechanical ventilation, intensive care unit (ICU) stay, and organ support from Day 1 to Day 28.
Phase I: Change in Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) from Baseline
The ratio is calculated by dividing the arterial partial pressure of oxygen by the fraction of inspired oxygen. Measurements will be taken at baseline and various time points from Day 1 to Day 28.
Phase I: Change in Arterial Potential of Hydrogen (pH) from Baseline
To evaluate the change in arterial pH from baseline at various time points from Day 1 to Day 28.
[Phase I & II] Immunogenicity Assessment: Anti-MHC Antibodies and Donor-Specific Antibodies (DSA)
Detection of allogeneic antibodies against Major Histocompatibility Complex (MHC) Class I and Class II. If positive, the Mean Fluorescence Intensity (MFI) of Donor-Specific Antibodies (DSA) will be measured. This applies to both Phase I and Phase II cohorts.
[Phase I & II] Pharmacokinetics (PK): Count of Allogeneic Invariant Natural Killer T (iNKT) Cells
Enumeration of allogeneic invariant natural killer T (iNKT) cells in peripheral blood post-treatment. This assessment is conducted in both Phase I and Phase II.
[Phase I & II] Pharmacodynamics (PD): Inflammatory Cytokines and Acute Phase Reactants
Measurement of changes in peripheral blood levels of: oC-reactive protein (CRP) oInterleukin-1 Receptor Antagonist (IL-1RA) oInterleukin-6 (IL-6) oInterleukin-8 (IL-8) oTumor Necrosis Factor-alpha (TNF-α) oInterferon-gamma (IFN-γ) Soluble Tumor Necrosis Factor Receptor 1 (sTNFr1)
[Phase I & II] Pharmacodynamics (PD): Serum Bicarbonate (HCO3-) Levels
Measurement of changes in serum bicarbonate (HCO3-) levels in peripheral blood post-treatment for both Phase I and Phase II cohorts.
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