Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
29 de maio de 2026 atualizado 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?
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
21
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jia Wei
- Número de telefone: 027-83663200
- E-mail: jiawei@tjh.tjmu.edu.cn
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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CRS
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Complete remission rate
Prazo: 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.
|
Assessments are performed every 3 months within the first two years after CAR-T infusion
|
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Objective Response Rate
Prazo: Assessments are performed every 3 months within the first two years after CAR-T infusion
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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
Prazo: Assessments are performed during the first two years following CAR-T infusion.
|
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
Prazo: 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
Prazo: 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
Prazo: 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
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Assessments are performed every 3 months within the first year after CAR-T infusion
|
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Adverse events
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jia Wei, Tongji Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
22 de maio de 2026
Conclusão Primária (Estimado)
31 de maio de 2029
Conclusão do estudo (Estimado)
31 de maio de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TJ-IRB202603111
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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Ensaios clínicos em Diammonium glycyrrhizinate Capsules
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CttqDesconhecidoHepatite crônica b | Inflamação do Fígado