Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diammonium glycyrrhizinate Capsules.
- Who it may be relevant to
- Registry conditions: Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single-Center, Prospective, Randomized Controlled Clinical Study of Oral Diammonium Glycyrrhizinate for Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
Overview
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?
Detailed description
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.
Interventions
- Drug Diammonium glycyrrhizinate Capsules
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).
Primary outcome measures
- CRS [Time frame: Within 28 days post CAR-T cell infusion]
Secondary outcome measures (7)
- Complete remission rate [Time frame: Assessments are performed every 3 months within the first two years after CAR-T infusion]
- Objective Response Rate [Time frame: Assessments are performed every 3 months within the first two years after CAR-T infusion]
- Duration of response [Time frame: Assessments are performed during the first two years following CAR-T infusion.]
- Overall survival [Time frame: Up to 2 years as per long-term follow-up mentions]
- Progression-free survival [Time frame: Assessments are performed during the first two years following CAR-T infusion]
- Level of CAR-T cell persistence [Time frame: Assessments are performed every 3 months within the first year after CAR-T infusion]
- Adverse events [Time frame: Assessments are performed during the first two years following CAR-T infusion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07616271 · TJ-IRB202603111