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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
21
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).
CRS
CRS incidence and incidence of grade ≥3 CRS
Time frame: Within 28 days post CAR-T cell infusion
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.
Time frame: Assessments are performed every 3 months within the first two years after CAR-T infusion
Objective Response Rate
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.
Time frame: 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.
Time frame: Assessments are performed during the first two years following CAR-T infusion.
Overall survival
The time from confirmed diagnosis to death from any cause.
Time frame: 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.
Time frame: Assessments are performed during the first two years following CAR-T infusion
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Level of CAR-T cell persistence
Duration of CAR-T cell persistence in patients
Time frame: Assessments are performed every 3 months within the first year after CAR-T infusion
Adverse events
Adverse events following CAR-T cell infusion
Time frame: Assessments are performed during the first two years following CAR-T infusion