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

NCT07709637 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-07-21

No results posted yet for this study

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.

Conditions

  • COVID-19
  • COVID-19 (SARS-CoV-2 Infection)

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.

Sponsors & Collaborators

  • LucasBio

    lead INDUSTRY

Principal Investigators

  • Dong-Gun Lee, MD-PhD · Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709637 on ClinicalTrials.gov