Terapia con Células CAR-T Biespecíficas CD19/CD22 para Linfoma de Células B Grandes Recaído/Refractario
Terapia con Células CAR-T Biespecíficas CD19/CD22 para Linfoma de Células B Grandes Recaído/Refractario: Un Ensayo Prospectivo, de Un Solo Brazo, en un Solo Centro, de Fase 2
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Large B cell lymphoma (LBCL) is the most common aggressive subtype of non-Hodgkin lymphoma (NHL) in adults. While approximately 60% of patients can be cured with first-line therapy, a subset of patients experiences relapse or refractory disease (R/R). The prognosis for R/R LBCL patients is poor, with limited efficacy from traditional treatments such as autologous stem cell transplantation (ASCT) and novel targeted agents. Chimeric antigen receptor-T (CAR-T) cell therapy involves genetically engineering T cells to express chimeric antigen receptors (CARs) that target tumor-specific antigens, enabling precise elimination of tumor cells. CD19 is the most commonly targeted antigen in B-cell malignancies, however, antigen escape following CD19 CAR-T therapy can lead to disease relapse in some patients. Studies indicate that CD22 is widely expressed in B-cell malignancies and exhibits incomplete overlap with CD19 expression, suggesting that dual-target CAR-T therapy may more comprehensively eradicate tumor cells. Therefore, dual-target CAR-T therapy, particularly strategies targeting both CD19 and CD22, has emerged as a promising approach to overcome antigen escape and enhance therapeutic outcomes. In this prospective study, the investigators aimed to evaluate the efficacy and safety of CD19/CD22 bispecific CAR-T cell (CAR2219) therapy in patients with R/R LBCL.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Beijing Tongren Hospital, Capital Medical University
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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:
- 14 years to 85 years, expected survival > 3 months;
- CD19 positive with or without CD22 positive Large B-cell lymphoma;
- relapsed or refractory disease;
- ECOG-PS score=0-2;
- Having at least one measurable lesion;
- Cardiac function: 1-2 levels;
- Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
- kidney: Cr≤1.25ULN;
- bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
- No serious allergic constitution;
- No other serious diseases that conflicts with the clinical program;
- No other cancer history;
- No serious mental disorder;
- Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
- Pregnant or lactating women (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past 4 weeks;
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
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: CD19/CD22 CAR-T group
Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19/CD22 bispecific CAR-T cells was 2×10e6/kg. |
CD19/CD22-bispecific CAR-T cells were infused at the dosage of 2×10e6/kg |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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best overall response rate (ORR) as of 3 months post-CAR-T cells infusion
Periodo de tiempo: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
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Overall response rate means sum of complete response rate and partial response rate |
From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Best Complete Response rate (CR) as of 3 months post-CAR-T cells infusion
Periodo de tiempo: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
|
CR was defined as complete response evaluated using PET-CT scan |
From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
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Progression free survival (PFS)
Periodo de tiempo: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason |
From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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overall survival (OS)
Periodo de tiempo: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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OS was defined from the date of CAR-T infusion to the date fo death |
From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Periodo de tiempo: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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measured using CTCAE version 5.0 |
From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Liang Wang, M.D., Beijing Tongren Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Otros números de identificación del estudio
- TRhos-CART-02
- 2025ZD0544300 (Otro número de subvención/financiamiento: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
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.
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