- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04237428
CD19-CART in the Treatment of R/R CD19 Positive Non-Hodgkin's Lymphoma
Clinical Study on the Treatment of Relapsed or Refractory CD19 Positive Non-Hodgkin's Lymphoma Patients With Target CD19 Chimeric Antigen Receptor T Cell Infusion
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Henan
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Zhengzhou, Henan, Porcelana, 450000
- Reclutamiento
- First Affiliated Hospital of Zhengzhou University
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Contacto:
- Min Yao, Bachelor's
- Número de teléfono: +8618355313511
- Correo electrónico: 1248135168@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Subjects with CD19 positive, relapsed or refractory diffuse large B cell lymphoma and follicular lymphoma who have no effective treatment (such as autologous or allogeneic stem cell transplantation) and have a survival time of several months or less than 2 years must meet all of the following inclusion criteria, and those who do not meet any of the exclusion criteria can be included:
Non Hodgkin's lymphoma was confirmed by histological examination, and one of the following conditions was met:
- Relapsed and refractory CD19 positive diffuse large B-cell lymphoma: at least after the standard second-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission or disease progression after partial remission, or relapsed after complete remission;
- Relapsed and refractory CD19 positive follicular lymphoma: at least after the standard three-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission and disease progress after partial remission, or relapsed after complete remission;
- Relapsed refractory CD19 positive diffuse large B-cell lymphoma and follicular lymphoma: primary drug resistance; relapse within 1 year after autologous stem cell transplantation only, not affected by other treatment methods previously used; CD20 positive patients should receive corresponding targeted treatment;
- Age: 18-65 years (including boundary value), gender unlimited;
- The expected survival time was more than 3 months;
- ECOG score 0-1 (dose increasing stage), ECoG score 0-2 (expanding group stage);
The functions of liver and kidney, heart and lung meet the following requirements:
① Creatinine ≤ 1.5 ULN
②ALT/AST ≤2.5 ULN;
③ Total bilirubin ≤ 1.5 × ULN;
④ Baseline oxygen saturation ≥ 92%;
⑤ No pericardial effusion was detected by echo;
- According to Lugano's response standard, there should be at least one measurable tumor focus;
- Be able to understand the test and have signed the informed consent.
Exclusion Criteria:
- Before screening, they received other chimeric antigen receptor therapy or gene modified cell therapy;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the DNA titer of peripheral blood hepatitis B virus (HBV) is not within the normal reference range; hepatitis C virus (HCV) antibody is positive and peripheral blood HCV RNA is positive; human immunodeficiency virus (HIV) antibody is positive; cytomegalovirus (CMV) DNA is positive; syphilis is positive ;
- Subjects who were undergoing systemic steroid therapy at the time of screening and who were determined by the investigator to require long-term systemic steroid therapy during the treatment (except for inhalation or local use);
- In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation, malignant tumors other than B-cell acute lymphoblastic leukemia in the first 5 years were screened;
- Subjects with graft-versus-host disease (GVHD), autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus and Crohn's disease) and / or requiring immunosuppressant within 2 years;
- Any unstable heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ grade III) and severe arrhythmia;
- Any unstable systemic diseases: including but not limited to liver, kidney or metabolic diseases requiring drug treatment;
- Subjects who received stem cell transplantation within 6 weeks after CD19 car-t infusion were planned;
- Invasion of central nervous system;
- Pregnant women and lactating women; and female subjects who plan pregnancy within 1 year after cell transfusion or male subjects whose partners plan pregnancy within 1 year after cell transfusion;
- According to the judgment of the researchers, it does not conform to the situation of cell preparation;
- Other researchers think it's not suitable for enrollment.
Plan de estudios
¿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: hCD19 CAR-T cells Infusion
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Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment. CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10^6/kg. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
BORR
Periodo de tiempo: 6 months
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Best objective response rate
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of AE
Periodo de tiempo: 2 years
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Incidence of adverse reactions
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2 years
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Pharmacokinetic parameters
Periodo de tiempo: 90 Days
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the area under the curve of 28 days AUC0-28d and 90 days AUC0-90d of targeting CD19 chimeric antigen receptor T cells in peripheral blood after administration
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90 Days
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Overall survival time
Periodo de tiempo: through study completion, an average of 5 year
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Overall survival time
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through study completion, an average of 5 year
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Duration of remission after administration
Periodo de tiempo: through study completion, an average of 5 year
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Duration of remission after administration
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through study completion, an average of 5 year
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Disease progression free survival
Periodo de tiempo: through study completion, an average of 5 year
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Disease progression free survival
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through study completion, an average of 5 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PG-CART-19-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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Rutgers, The State University of New JerseyTerminadoMBSR-STEM | PMR-STEM | MBSR-NON-STEM | PMR - SIN VÁSTAGOEstados Unidos
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National Cancer Institute (NCI)TerminadoLinfoma de Hodgkin en adultos recidivante | Linfoma de Hodgkin en adultos en estadio III | Linfoma de Hodgkin en adultos en estadio IV | Linfoma de Hodgkin infantil recidivante/refractario | Linfoma de Hodgkin infantil en estadio III | Linfoma de Hodgkin infantil en estadio IV | Linfoma de Hodgkin... y otras condicionesEstados Unidos
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GenmabReclutamientoNo linfoma de Hodgkin | Linfoma de Hodgkin clásicoEstados Unidos, Australia
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