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ACTIVE NOT RECRUITING
NCT07709637
PHASE1

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

Sponsor: LucasBio

View on ClinicalTrials.gov

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.

Official title: A Single Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerance, and Efficacy of Allogeneic LB-DTK-COV19 Cells in Severe Coronavirus Disease 2019 Patients

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1

Start Date

2025-07-31

Completion Date

2026-07-31

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

LB-DTK-COV19

LB-DTK-COV19 is an allogeneic SARS-CoV-2-specific T cell therapy product derived from third-party donors and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.

Locations (1)

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, South Korea