Safety and Efficacy Study of GKL-006RTU in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS)

Summary

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.

Timeline

Start

2026-07-10

Primary completion

2027-07-30

Completion

2027-07-30

Drugs

Indications