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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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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| Control group | No Intervention | For the control group, after CAR-T cell infusion, standard clinical care is provided without additional diammonium glycyrrhizinate intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diammonium glycyrrhizinate Capsules | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| CRS | CRS incidence and incidence of grade ≥3 CRS | Within 28 days post CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Wei | Contact | 027-83663200 | jiawei@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jia Wei | Tongji Hospital | Principal Investigator |
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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). For the control group, after CAR-T cell infusion, standard clinical care is provided without additional diammonium glycyrrhizinate intervention.
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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. |
| Assessments are performed every 3 months within the first two years after CAR-T infusion |
| Duration of response | 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. |
| Overall survival | The time from confirmed diagnosis to death from any cause. | Up to 2 years as per long-term follow-up mentions |
| Progression-free survival | 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 | Duration of CAR-T cell persistence in patients | Assessments are performed every 3 months within the first year after CAR-T infusion |
| Adverse events | Adverse events following CAR-T cell infusion | Assessments are performed during the first two years following CAR-T infusion |
| ID | Term |
|---|---|
| D019695 | Glycyrrhizic Acid |
| ID | Term |
|---|---|
| D053978 | Pentacyclic Triterpenes |
| D014315 | Triterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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