CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
7 de mayo de 2026 actualizado por: Cellenkos, Inc.
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
This clinical trial will be conducted in two parts where the first part of Phase 1b will determine the safety and tolerability of CK0802 in patients with steroid refractory GVHD and the second part of Phase 2a will examine the preliminary efficacy of CK0802 in patients with steroid refractory GVHD
Tipo de estudio
Intervencionista
Inscripción (Estimado)
12
Fase
- Fase 2
- Fase 1
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: Clinical Trial Specialist
- Número de teléfono: 8002178247
- Correo electrónico: contact@cellenkosinc.com
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
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 1. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
- 2. Grade 2-4 acute GVHD (aGVHD) at baseline
- 3. No other prior aGVHD treatment
- 4. Steroid Refractory
- Progressed after 3 days of treatment with 2 mg/kg methylprednisolone (MPE)
- No improvement after 7 days of treatment with 2 mg/kg MPE
- Progressed to a new organ after treatment with 1 mg/kg MPE for skin or upper gastrointestinal (UGI) aGVHD
- Progressed from nadir during or after a steroid taper
- 5. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.
- 6. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
- 7. Willing and able to provide written informed consent.
- 8. Signed informed consent
Exclusion Criteria:
- 1. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
- 2. Known HIV seropositivity.
- 3. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- 4. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802.
- 5. Subjects who are pregnant or breastfeeding.
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 |
|---|---|
|
Experimental: Treatment Arm
CK0802 Tregs will be administered intravenously at a fixed dose of 100 million Treg cells.
|
Subjects will receive seven planned doses of CK0802 on study day +1, +3 (+/-1 day), +5 (+/-1 day), +7 (+/- 2 day), +14 (+/- 3 days), +21 (+/-3 days) and +28 (+/-3 days). A total of 7 doses will be administered. If Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+/- 2 day), 42 (+/- 2 day), 49 (+/- 2 day), and 55(+/- 2 day)), for a total of 11 infusions |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1b
Periodo de tiempo: Day +29
|
Dose limiting toxicities of CK0802 in SR GVHD as assessed by the incidence and severity of AE and SAEs determined by the NCI-CTCAE Version 6.0. Non-Hematologic: Any ≥ Grade 3 non-hematologic AE as per CTCAE v6.0 Hematologic: Any new or worsened Grade 4 neutropenia, thrombocytopenia, or anemia compared with baseline that persists for >7 days despite supportive care and is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause. Death: Death within 28 days that is not clearly and incontrovertibly attributable to the underlying disease or another extraneous cause |
Day +29
|
|
Phase 2a
Periodo de tiempo: D +29
|
Overall Response (OR) at day +29. Overall response (OR) will include complete response (CR) and partial response (PR). Response to be determined from the maximum acute GVHD stage and grade in each organ. Complete Response (CR): Stage 0 in all organs (skin, liver, and GI tract) and no intervening additional therapy Partial Response (PR): Improvement of at least 1 stage in 1 or more organs without progression in other organs, and no intervening additional therapy Overall Response (OR): Includes both CR and PR Very Good PR (VGPR): Improvement by at least one stage in one or more organs and
|
D +29
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
30 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de mayo de 2026
Publicado por primera vez (Actual)
8 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedad de injerto contra huésped
- Técnicas de investigación
- Terapéutica
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Técnicas citológicas
- Técnicas histológicas
- Preservación del tejido
- Preservación, biológica
- Técnicas de preparación histocitológica
- Criopreservación
Otros números de identificación del estudio
- CK0802-101-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
IPD can be shared based on request and after proper de-identifiers to protect individual patient information is in place.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
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. .