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Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL

23 de mayo de 2026 actualizado por: Zhao Weili, Ruijin Hospital

A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma

This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • Fase 2

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: Weili Zhao
  • Número de teléfono: +862164370045 Ext. 610707
  • Correo electrónico: zwl_trial@163.com

Copia de seguridad de contactos de estudio

  • Nombre: Rong Shen
  • Número de teléfono: +862164370045 Ext. 610707
  • Correo electrónico: rongshen510@yeah.net

Ubicaciones de estudio

    • China
      • Shanghai, China, Porcelana, 200020
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Able to understand and voluntarily sign the written informed consent form.
  • Age 18 years or older.
  • Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression.
  • Relapsed or refractory disease after at least one prior line of systemic therapy.
  • Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody.
  • Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy.
  • Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality.
  • ECOG performance status of 0 to 2.
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator.
  • Participants of reproductive potential must agree to use effective contraception during the study period.
  • Able and willing to comply with the study protocol, in the investigator's judgment.

Exclusion Criteria:

  • History of hypersensitivity to any study treatment or related compounds.
  • Active or uncontrolled infection requiring systemic treatment.
  • History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • Uncontrolled or clinically significant viral infection as defined by the protocol.
  • Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment.
  • Severe or uncontrolled cardiovascular disease.
  • Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment.
  • Known or suspected history of hemophagocytic lymphohistiocytosis.
  • Recent thromboembolic event before screening.
  • History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer.
  • Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment.
  • Pregnant or breastfeeding women, or participants planning pregnancy during the study period.
  • Concurrent participation in another interventional clinical trial.
  • Need for prohibited concomitant medications that cannot be discontinued or substituted.
  • Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study participation.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy
Participants will receive rimegepant in combination with glofitamab and CD19 CAR-T cell therapy. Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.
Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.
Glofitamab will be administered intravenously with step-up dosing. Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.
Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy. The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.
Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Comparador activo: Glofitamab Plus CD19 CAR-T Cell Therapy
Participants will receive glofitamab in combination with CD19 CAR-T cell therapy. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.
Glofitamab will be administered intravenously with step-up dosing. Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.
Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy. The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.
Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Complete Response Rate at 6 Months
Periodo de tiempo: 6 months after CAR-T cell infusion
Complete response rate at 6 months is defined as the proportion of participants who achieve complete response at 6 months after CAR-T cell infusion.
6 months after CAR-T cell infusion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate
Periodo de tiempo: Up to 24 months
Objective response rate is defined as the proportion of participants who achieve complete response or partial response.
Up to 24 months
Complete Response Rate at Day 28
Periodo de tiempo: Day 28 after CAR-T cell infusion
Complete response rate at Day 28 is defined as the proportion of participants who achieve complete response at Day 28 after CAR-T cell infusion.
Day 28 after CAR-T cell infusion
Complete Response Rate at 3 Months
Periodo de tiempo: 3 months after CAR-T cell infusion
Complete response rate at 3 months is defined as the proportion of participants who achieve complete response at 3 months after CAR-T cell infusion.
3 months after CAR-T cell infusion
Progression-Free Survival
Periodo de tiempo: Up to 24 months
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
Up to 24 months
Duration of Response
Periodo de tiempo: Up to 24 months
Duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.
Up to 24 months
Overall Survival
Periodo de tiempo: Up to 24 months
Overall survival is defined as the time from randomization to death from any cause.
Up to 24 months
Adverse Events
Periodo de tiempo: Up to 24 months
Incidence and severity of adverse events will be assessed throughout the study.
Up to 24 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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 mayo de 2026

Finalización primaria (Estimado)

1 de noviembre de 2028

Finalización del estudio (Estimado)

1 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

23 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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