Evaluation of the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell in Prolonged SARS-CoV-2 Patients
NCT07690943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2026-07-08
Summary
The goal of this clinical study is to evaluate the safety and efficacy of autologous COVID-19 antigen specific T cell (LB-DTK-COV19) treatment in prolonged SARS-CoV-2 infected patients. The main questions it aims to answer are:
* What adverse events occur after the infusion of LB-DTK-COV19?
* Is there a clinically significant improvement in clinical symptoms within 4 weeks after the infusion?
* Is there a clinically significant reduction in SARS-CoV-2 viral load within 4 weeks after the infusion?
The patients will:
* Receive a single infusion of LB-DTK-COV19 either intravenously or using central venous catheter during the baseline visit at a dose of 1x10\^7/m\^2.
* Receive a second infusion of LB-DTK-COV19 either intravenously or using central venous catheter at the same dose 14 days after the first infusion.
* Attend follow-up visits at the clinic for 6 months after the first infusion.
Conditions
- COVID-19
- COVID-19 (SARS-CoV-2 Infection)
Interventions
- BIOLOGICAL
-
LB-DTK-COV19
\- LB-DTK-COV19 is an autologous SARS-CoV-2-specific T cell therapy product derived from a patient and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.
Sponsors & Collaborators
-
LucasBio
lead INDUSTRY
Principal Investigators
-
Rae Seok 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
- 2023-06-08
- Primary Completion
- 2024-05-31
- Completion
- 2025-01-22
Countries
- South Korea
Study Locations
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