3
Clinical Trials associated with LB-DTK-COV19A single center, open-label, phase I study to evaluate the safety, tolerance and efficacy of LB-DTK-COV19 in severe Coronavirus Disease 2019 patients
Start Date31 Jul 2025 |
Sponsor / Collaborator- |
/ Active, not recruitingPhase 1 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
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.
/ CompletedNot Applicable A Clinical Study to Evaluate the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell Treatment in Prolonged SARS-CoV-2 Infected Patients
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.
100 Clinical Results associated with LB-DTK-COV19
100 Translational Medicine associated with LB-DTK-COV19
100 Patents (Medical) associated with LB-DTK-COV19
100 Deals associated with LB-DTK-COV19