Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy

NCT07616271 | Not Yet Recruiting Phase 2

• 1 other identifier: TJ-IRB202603111
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy

Keywords

Large B-cell lymphoma; Diammonium Glycyrrhizinate; CAR-T cell therapy; Toxicity reducing and efficacy enhancing

Outcome Measures

Primary Outcomes (1)

• CRS

  CRS incidence and incidence of grade ≥3 CRS

  Within 28 days post CAR-T cell infusion

Secondary Outcomes (7)

• Complete remission rate

  Assessments are performed every 3 months within the first two years after CAR-T infusion

• Objective Response Rate

  Assessments are performed every 3 months within the first two years after CAR-T infusion

• Duration of response

  Assessments are performed during the first two years following CAR-T infusion.

• Overall survival

  Up to 2 years as per long-term follow-up mentions

• Progression-free survival

  Assessments are performed during the first two years following CAR-T infusion

Study Arms (2)

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).

Drug: Diammonium glycyrrhizinate Capsules

Control group

NO INTERVENTION

For the control group, after CAR-T cell infusion, standard clinical care is provided without additional diammonium glycyrrhizinate intervention.

Interventions

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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

Glycyrrhizic Acid

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Jia Wei

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Wei

CONTACT

027-83663200; jiawei@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share