Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
29 de junio de 2026 actualizado por: JaeWon Yoo, LucasBio
A Prospective Clinical Study to Evaluate the Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:
- What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?
- What treatment emergent adverse events occur within 14 days after the second infusion?
- Is there a clinically significant reduction in CMV, EBV, and BKV viral loads within 14 days following the second infusion?
- Is there a clinically significant improvement in clinical symptoms within 14 days following the second infusion?
Participants will:
- Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10^7/m^2; high dose: 2x10^7/m^2).
- Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.
- Attend weekly follow-up visits at the clinic for 6 months after the first infusion.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
6
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Nayoun Kim, Ph.D.
- Número de teléfono: +82 1040222340
- Correo electrónico: nkim@lucasbio.com
Ubicaciones de estudio
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Seoul, Corea del Sur, 06591
- Reclutamiento
- The Catholic University of Korea Seoul ST.MARY'S Hospital
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Investigador principal:
- Jae-won Yoo, MD-PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to standard-of-care treatment and associated with severe complications following allogeneic hematopoietic stem cell transplantation at the ages of 1-25 years.
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10^3/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
- Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
- Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Exclusion Criteria:
- Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.
Patients with organ failures and/or uncontrolled bacterial or fungal infections.
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)]
- Chronic kidney disease [eGFR < 30mL/min/1.73m^2]
- Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
- Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
- Patients with active malignant tumor or uncontrolled recurrence.
- Patients deemed ineligible for participation in this clinical study by the investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Experimental Group (All, ped)
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LB-DTK-MV is a virus-specific T cell therapy product derived from a designated donor and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.
Study participants will receive a single intravenous infusion of the assigned cell dose (low dose: 1x10^7/m^2;high dose: 2x10^7/m^2) of LB-DTK-MV on Visit 2 and 14 days after the initial infusion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Viral Load
Periodo de tiempo: From enrollment through 24 weeks after treatment initiation
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CMV, EBV, and BKV viral load testing is performed using RT-PCR on blood, urine, and/or tissue samples.
Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
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From enrollment through 24 weeks after treatment initiation
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Immunogenicity Testing
Periodo de tiempo: From enrollment through 24 weeks after treatment initiation.
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Immunogenicity testing using the ELISpot assay is performed weekly for the first 4 weeks following administration of the investigational drug.
Thereafter, to evaluate the persistence and reconstitution of the immune response, measurements are taken twice at 2-week intervals, once at 4-week intervals, and once at 12-week intervals.
Flow cytometry will be performed concurrently at each time point to evaluate cytokine profiles and immune cell subsets.
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From enrollment through 24 weeks after treatment initiation.
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Adverse Events
Periodo de tiempo: From the baseline visit through 24 weeks after treatment initiation.
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The investigator must confirm the occurrence of adverse events through medical examinations during regular visits throughout the clinical study period.
Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit (Visit 2).
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From the baseline visit through 24 weeks after treatment initiation.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jae-won Yoo, MD-PhD, Department of Pediatrics, The Catholic University of Korea Seoul St.Mary's Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de febrero de 2026
Finalización primaria (Estimado)
20 de mayo de 2027
Finalización del estudio (Estimado)
20 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
29 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2026
Publicado por primera vez (Actual)
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LB-DD-DTK-MV-HS-PD-CR
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .