Evaluation of Safety, Tolerance, and Efficacy of Allogeneic LB-DTK-COV19 in Severe Coronavirus Disease 2019 Patients

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of allogeneic SARS-CoV-2-Specific T cells (LB-DTK-COV19) in patients with persistent clinical symptoms following a positive SARS-CoV-2 PCR test for 14 days or longer. The main questions it aims to answer are: * What is the maximum tolerated dose of LB-DTK-COV19 based on dose-limiting toxicity? * What treatment emergent adverse events occur following LB-DTK-COV19 infusion? * Does LB-DTK-COV19 result in clinically significant improvement or worsening of clinical symptoms following infusion? Participants will: * Receive a single intravenous infusion of LB-DTK-COV19 (low dose: 5x10\^6/m\^2; mid dose:1x10\^7/m\^2; high dose: 2x10\^7/m\^2). * Attend follow-up visits at the clinic for 6 months after the infusion.

Timeline

Start

2025-07-31

Primary completion

2026-07-31

Completion

2026-07-31

Publications

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• Background Korean Pharmaceutical Information Center Library and Information. Understanding of Coronavirus, 2020
• Background Korea Disease Control and Prevention Agency. Coronavirus Disease-2019 (COVID 19), http://ncov.mohw.go.kr/
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• Background PG Choe. Vaccines and Treatment of Coronavirus Disease 2019, The Korean Journal of Medicine 2020; 95(6): 364-369.

Drugs

Indications