Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
29 de mayo de 2026 actualizado por: Jia Wei, Tongji Hospital
A Single-Center, Prospective, Randomized Controlled Clinical Study of Oral Diammonium Glycyrrhizinate for Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
The purpose of this study is to evaluate the effect of oral diammonium glycyrrhizinate in reducing toxicity and enhancing efficacy of CAR-T cell therapy in patients with large B-cell lymphoma.
Two main questions are addressed: 1) Can oral diammonium glycyrrhizinate reduce the incidence and severity of CRS induced by CAR-T cells?
2) Can oral diammonium glycyrrhizinate synergistically increase the therapeutic efficacy of CAR-T cell therapy?
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Current studies suggest that regulating pyroptosis may play a role in reducing toxicity and enhancing efficacy during CAR-T cell therapy by alleviating cytokine release syndrome (CRS) and improving the tumor microenvironment (TME).
Glycyrrhizic acid has been clearly shown to inhibit pyroptosis and is widely recognized for its broad-spectrum anti-inflammatory effects and ability to improve the TME.
Therefore, it holds promise as an ideal intervention for preventing/treating CRS induced by CAR-T cells and for synergistically enhancing the therapeutic efficacy of CAR-T cell therapy.
Accordingly, this study aims to investigate the effect of oral diammonium glycyrrhizinate in reducing toxicity and enhancing efficacy of CAR-T cell therapy in patients with large B-cell lymphoma.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
21
Fase
Fase
- Fase 2
- Fase 3
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
Estudio Contacto
- Nombre: Jia Wei
- Número de teléfono: 027-83663200
- Correo electrónico: jiawei@tjh.tjmu.edu.cn
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
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥ 18 years.
- Patients diagnosed with large B-cell lymphoma and receiving CAR-T cell therapy.
- Adequate organ function prior to enrollment: ALT and AST ≤ 2.5 × ULN (upper limit of normal); may be extended to ≤5 × ULN in patients with liver involvement; serum total bilirubin < 34 μmol/L; creatinine clearance > 30 mL/min; cardiac ejection fraction (EF) ≥ 40%, with no pericardial effusion or significant arrhythmia; room air SpO₂ ≥ 92%.
- No central nervous system involvement of lymphoma confirmed by MRI prior to enrollment.
- Subjects of childbearing potential must agree to use highly effective contraceptive methods.
- The subject or their legal guardian must be able to understand and voluntarily sign a written informed consent form.
Exclusion Criteria:
- Presence of a prior malignancy (other than the disease under study) that requires ongoing systemic treatment for any other malignant tumor.
- Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's judgment, may compromise patient safety or interfere with the interpretation of safety or efficacy data.
- Current or prior central nervous system (CNS) involvement by malignancy.
- Receipt of allogeneic stem cell transplantation within 6 months prior to enrollment, or autologous stem cell transplantation within 3 months prior to enrollment; and the patient must have no signs or symptoms of graft-versus-host disease and must not be receiving immunosuppressive therapy.
- Intolerance or allergy to glycyrrhizic acid preparations.
- Patient refuses to comply with the study requirements to complete the research work.
- In the investigator's judgment, the patient is unable to complete the study or comply with the study requirements (due to administrative reasons or other reasons), or is considered unsuitable for clinical trial participation for other reasons.
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: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Experimental group
At the time of CAR-T cell infusion, oral diammonium glycyrrhizinate is given in addition to standard clinical care (first two weeks: 150 mg three times daily; thereafter, 100 mg once daily, continued orally for 2 years).
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For the experimental group, at the time of CAR-T cell infusion, oral diammonium glycyrrhizinate is given in addition to standard clinical care (first two weeks: 150 mg three times daily; thereafter, 100 mg once daily, continued orally for 2 years).
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Sin intervención: Control group
For the control group, after CAR-T cell infusion, standard clinical care is provided without additional diammonium glycyrrhizinate intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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CRS
Periodo de tiempo: Within 28 days post CAR-T cell infusion
|
CRS incidence and incidence of grade ≥3 CRS
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Within 28 days post CAR-T cell infusion
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Complete remission rate
Periodo de tiempo: Assessments are performed every 3 months within the first two years after CAR-T infusion
|
Proportion of participants achieving Complete Response (CR) at the end of treatment.
Efficacy is evaluated by both investigators and independent imaging personnel based on PET-CT or CT.
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Assessments are performed every 3 months within the first two years after CAR-T infusion
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Objective Response Rate
Periodo de tiempo: Assessments are performed every 3 months within the first two years after CAR-T infusion
|
Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Efficacy is evaluated by both investigators and independent imaging personnel based on PET-CT or CT.
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Assessments are performed every 3 months within the first two years after CAR-T infusion
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Duration of response
Periodo de tiempo: Assessments are performed during the first two years following CAR-T infusion.
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Time from documentation of tumor response (CR or PR) to disease progression or death.
Efficacy is evaluated by both investigators and independent imaging personnel based on PET-CT or CT.
|
Assessments are performed during the first two years following CAR-T infusion.
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Overall survival
Periodo de tiempo: Up to 2 years as per long-term follow-up mentions
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The time from confirmed diagnosis to death from any cause.
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Up to 2 years as per long-term follow-up mentions
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Progression-free survival
Periodo de tiempo: Assessments are performed during the first two years following CAR-T infusion
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The time interval from the start of treatment to tumor progression (PD) or death from any cause.
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Assessments are performed during the first two years following CAR-T infusion
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Level of CAR-T cell persistence
Periodo de tiempo: Assessments are performed every 3 months within the first year after CAR-T infusion
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Duration of CAR-T cell persistence in patients
|
Assessments are performed every 3 months within the first year after CAR-T infusion
|
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Adverse events
Periodo de tiempo: Assessments are performed during the first two years following CAR-T infusion
|
Adverse events following CAR-T cell infusion
|
Assessments are performed during the first two years following CAR-T infusion
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Jia Wei, Tongji Hospital
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)
Inicio del estudio
22 de mayo de 2026
Finalización primaria (Estimado)
Finalización primaria
31 de mayo de 2029
Finalización del estudio (Estimado)
Finalización del estudio
31 de mayo de 2030
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
1 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
1 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- TJ-IRB202603111
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
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