Clinical Trials | LUCASBIO

Evaluation of the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell in Prolonged SARS-CoV-2 Patients

Autologous SARS-CoV-2 specific T cells (Product Name LB-DTK-COV19) are derived from patients who remain SARS-CoV-2 positive for more than 21 days and are either moderately immunocompromised or refractory to standard-of-care treatment. This clinical study is a mid-risk, single-center, open-label advanced regenerative medicine study conducted in South Korea to evaluate the safety and efficacy of LB-DTK-COV19.

*Mid-Risk Advanced Regenerative Medicine Clinical Study involves interventions that may pose potential risks to human life or health and therefore require a significant level of caution.

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

Allogeneic SARS-CoV-2 specific T cells (Product Name LB-DTK-COV19) are derived from third-party donors for the treatment of patients with COVID-19 confirmed by RT-PCR testing and severe symptoms. This Phase 1 study is an interventional, single-center, open-label trial designed to evaluate the safety, tolerability, and efficacy of LB-DTK-COV19 in patients with severe SARS-CoV-2 infection.

Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic multivirus (CMV, EBV, BKV) specific T cells (Product name LB-DTK-MV) are derived from third-party donors for the treatment of patients with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation. The Phase 1 study is designed to evaluate the safety of LB-DTK-MV based on the maximum tolerated dose and treatment-emergent adverse events. The Phase 2 study is intended to assess the efficacy of LB-DTK-MV, with endpoints including viral load reduction and improvement in clinical symptoms. Both studies are single-center, open-label trials evaluating LB-DTK-MV for the treatment of patients with multiple viral infections.

Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic (1:1) multivirus (CMV, EBV, BKV) specific T cells (Product name LB-DTK-MV) are derived from designated donors for the treatment of pediatric patients aged 1–25 years with systemic viral infections caused by CMV, EBV, or BKV following allogeneic hematopoietic stem cell transplantation. This clinical study is a high-risk, single-center, open-label advanced regenerative medicine study conducted in South Korea to evaluate the safety and efficacy of LB-DTK-MV.

*High-Risk Advanced Regenerative Medicine Clinical Study involves interventions whose effects on human life or health are uncertain or that pose a high level of risk to human life or health.

Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.

Autologous CMV specific T cells (Product name LB-DTK-CMV) are derived from patients with antiviral-resistant and refractory CMV retinitis following hematopoietic stem cell transplantation for the treatment of hematologic malignancies, solid organ transplantation, or administration of high-dose immunosuppressive therapy for autoimmune diseases. This clinical study is a mid-risk, single-center, open-label advanced regenerative medicine study conducted in South Korea to evaluate the safety and efficacy of LB-DTK-CMV.

*Mid-Risk Advanced Regenerative Medicine Clinical Study involves interventions that may pose potential risks to human life or health and therefore require a significant level of caution.

Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation

Allogeneic (1:1) BKV specific T cells (Product name LB-DTK-BKV) are derived from designated donors for the treatment of pediatric, adolescent, and adult patients with BKV-associated hemorrhagic cystitis following allogeneic hematopoietic stem cell transplantation. The Phase 1 study is designed to evaluate the safety and tolerability of LB-DTK-BKV based on maximum tolerated dose and treatment-emergent adverse events. The Phase 2 study is intended to confirm efficacy and assess long-term safety, with endpoints including viral load reduction, improvement in clinical symptoms, and adverse events occurring within 6 months after the first dose.

Evaluation of the Safety of Cytokine-Induced-Killer Cells During Early Transplant Period of Autologous Hematopoietic Stem Cell Transplant Recipients.

Autologous CIK cells are derived from patients prior to autologous hematopoietic stem cell transplantation and subsequently infused during the early post-transplant period. This clinical study is a mid-risk, single-center, open-label advanced regenerative medicine study conducted in South Korea to evaluate the safety and efficacy of CIK cells for the elimination of residual tumor in autologous hematopoietic stem cell transplant recipients.

*Mid-Risk Advanced Regenerative Medicine Clinical Study involves interventions that may pose potential risks to human life or health and therefore require a significant level of caution.