Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
2026年5月29日 更新者：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?
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
21
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jia Wei
- 电话号码：027-83663200
- 邮箱：jiawei@tjh.tjmu.edu.cn
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
|
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).
|
|
无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CRS
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete remission rate
大体时间：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
|
|
Objective Response Rate
大体时间：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.
|
Assessments are performed every 3 months within the first two years after CAR-T infusion
|
|
Duration of response
大体时间：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
大体时间：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.
|
Up to 2 years as per long-term follow-up mentions
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Progression-free survival
大体时间：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.
|
Assessments are performed during the first two years following CAR-T infusion
|
|
Level of CAR-T cell persistence
大体时间：Assessments are performed every 3 months within the first year after CAR-T infusion
|
Duration of CAR-T cell persistence in patients
|
Assessments are performed every 3 months within the first year after CAR-T infusion
|
|
Adverse events
大体时间：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
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jia Wei、Tongji Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月22日
初级完成 (估计的)
2029年5月31日
研究完成 (估计的)
2030年5月31日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- TJ-IRB202603111
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