Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
29 mai 2026 mis à jour par: Jia Wei, Tongji Hospital
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?
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
21
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jia Wei
- Numéro de téléphone: 027-83663200
- E-mail: jiawei@tjh.tjmu.edu.cn
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
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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).
|
|
Aucune intervention: Control group
For the control group, after CAR-T cell infusion, standard clinical care is provided without additional diammonium glycyrrhizinate intervention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
CRS
Délai: Within 28 days post CAR-T cell infusion
|
CRS incidence and incidence of grade ≥3 CRS
|
Within 28 days post CAR-T cell infusion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete remission rate
Délai: Assessments are performed every 3 months within the first two years after CAR-T infusion
|
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.
|
Assessments are performed every 3 months within the first two years after CAR-T infusion
|
|
Objective Response Rate
Délai: Assessments are performed every 3 months within the first two years after CAR-T infusion
|
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.
|
Assessments are performed every 3 months within the first two years after CAR-T infusion
|
|
Duration of response
Délai: Assessments are performed during the first two years following CAR-T infusion.
|
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.
|
Assessments are performed during the first two years following CAR-T infusion.
|
|
Overall survival
Délai: Up to 2 years as per long-term follow-up mentions
|
The time from confirmed diagnosis to death from any cause.
|
Up to 2 years as per long-term follow-up mentions
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Progression-free survival
Délai: Assessments are performed during the first two years following CAR-T infusion
|
The time interval from the start of treatment to tumor progression (PD) or death from any cause.
|
Assessments are performed during the first two years following CAR-T infusion
|
|
Level of CAR-T cell persistence
Délai: Assessments are performed every 3 months within the first year after CAR-T infusion
|
Duration of CAR-T cell persistence in patients
|
Assessments are performed every 3 months within the first year after CAR-T infusion
|
|
Adverse events
Délai: Assessments are performed during the first two years following CAR-T infusion
|
Adverse events following CAR-T cell infusion
|
Assessments are performed during the first two years following CAR-T infusion
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jia Wei, Tongji Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
22 mai 2026
Achèvement primaire (Estimé)
31 mai 2029
Achèvement de l'étude (Estimé)
31 mai 2030
Dates d'inscription aux études
Première soumission
21 mai 2026
Première soumission répondant aux critères de contrôle qualité
29 mai 2026
Première publication (Réel)
1 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TJ-IRB202603111
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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