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?
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.
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.
Parallel
Diammonium glycyrrhizinate Capsules
DrugFor 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
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.
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.
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.
Overall survival
The time from confirmed diagnosis to death from any cause.
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