Patients With Large B-cell Lymphoma Receiving CAR-T Cell TherapyPhase 2/3NCT07616271
Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
A Phase 2/3 study testing Diammonium glycyrrhizinate Capsules in people with Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy
- What is being tested?
- Diammonium glycyrrhizinate Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2026to 31 May 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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?
Read the 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.
- Being tested
- Diammonium glycyrrhizinate Capsules
- Keywords
- Large B-cell lymphoma, Diammonium Glycyrrhizinate, CAR-T cell therapy, Toxicity reducing and efficacy enhancing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diammonium glycyrrhizinate CapsulesDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRS
CRS incidence and incidence of grade ≥3 CRS
Measured: Within 28 days post CAR-T cell infusion
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Assessments are performed during the first two years following CAR-T infusion.
Overall survival
The time from confirmed diagnosis to death from any cause.
Measured: 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.
Measured: 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
Measured: Assessments are performed every 3 months within the first year after CAR-T infusion
Adverse events
Adverse events following CAR-T cell infusion
Measured: Assessments are performed during the first two years following CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start22 May 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Large B-cell Lymphoma Receiving CAR-T Cell TherapyStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Wei, Tongji Hospital
- Investigators
- Jia Wei, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616271
- Sponsor's protocol ID
- TJ-IRB202603111
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07616271
- Acronym / sponsor ID
- TJ-IRB202603111
- Keywords
- Large B-cell lymphoma, Diammonium Glycyrrhizinate, CAR-T cell therapy, Toxicity reducing and efficacy enhancing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 22 May 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Diammonium glycyrrhizinate CapsulesAt 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). |
| Control group | No intervention | –For the control group, after CAR-T cell infusion, standard clinical care is provided without additional diammonium glycyrrhizinate intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diammonium glycyrrhizinate CapsulesFor 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). | Drug | Experimental group |
Primary outcome
CRS
Time frame: Within 28 days post CAR-T cell infusion
CRS incidence and incidence of grade ≥3 CRS
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jia Wei principal investigator
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Diammonium glycyrrhizinate Capsules in people with Patients With Large B-cell Lymphoma Receiving CAR-T Cell Therapy, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Wei (027-83663200, jiawei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRS (time frame: Within 28 days post CAR-T cell infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.