- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04237428
CD19-CART in the Treatment of R/R CD19 Positive Non-Hodgkin's Lymphoma
Clinical Study on the Treatment of Relapsed or Refractory CD19 Positive Non-Hodgkin's Lymphoma Patients With Target CD19 Chimeric Antigen Receptor T Cell Infusion
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Henan
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Zhengzhou, Henan, Chine, 450000
- Recrutement
- First Affiliated Hospital of Zhengzhou University
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Contact:
- Min Yao, Bachelor's
- Numéro de téléphone: +8618355313511
- E-mail: 1248135168@qq.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Subjects with CD19 positive, relapsed or refractory diffuse large B cell lymphoma and follicular lymphoma who have no effective treatment (such as autologous or allogeneic stem cell transplantation) and have a survival time of several months or less than 2 years must meet all of the following inclusion criteria, and those who do not meet any of the exclusion criteria can be included:
Non Hodgkin's lymphoma was confirmed by histological examination, and one of the following conditions was met:
- Relapsed and refractory CD19 positive diffuse large B-cell lymphoma: at least after the standard second-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission or disease progression after partial remission, or relapsed after complete remission;
- Relapsed and refractory CD19 positive follicular lymphoma: at least after the standard three-line drug treatment, the efficacy evaluation did not reach partial remission or above, or reached partial remission and disease progress after partial remission, or relapsed after complete remission;
- Relapsed refractory CD19 positive diffuse large B-cell lymphoma and follicular lymphoma: primary drug resistance; relapse within 1 year after autologous stem cell transplantation only, not affected by other treatment methods previously used; CD20 positive patients should receive corresponding targeted treatment;
- Age: 18-65 years (including boundary value), gender unlimited;
- The expected survival time was more than 3 months;
- ECOG score 0-1 (dose increasing stage), ECoG score 0-2 (expanding group stage);
The functions of liver and kidney, heart and lung meet the following requirements:
① Creatinine ≤ 1.5 ULN
②ALT/AST ≤2.5 ULN;
③ Total bilirubin ≤ 1.5 × ULN;
④ Baseline oxygen saturation ≥ 92%;
⑤ No pericardial effusion was detected by echo;
- According to Lugano's response standard, there should be at least one measurable tumor focus;
- Be able to understand the test and have signed the informed consent.
Exclusion Criteria:
- Before screening, they received other chimeric antigen receptor therapy or gene modified cell therapy;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the DNA titer of peripheral blood hepatitis B virus (HBV) is not within the normal reference range; hepatitis C virus (HCV) antibody is positive and peripheral blood HCV RNA is positive; human immunodeficiency virus (HIV) antibody is positive; cytomegalovirus (CMV) DNA is positive; syphilis is positive ;
- Subjects who were undergoing systemic steroid therapy at the time of screening and who were determined by the investigator to require long-term systemic steroid therapy during the treatment (except for inhalation or local use);
- In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation, malignant tumors other than B-cell acute lymphoblastic leukemia in the first 5 years were screened;
- Subjects with graft-versus-host disease (GVHD), autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus and Crohn's disease) and / or requiring immunosuppressant within 2 years;
- Any unstable heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ grade III) and severe arrhythmia;
- Any unstable systemic diseases: including but not limited to liver, kidney or metabolic diseases requiring drug treatment;
- Subjects who received stem cell transplantation within 6 weeks after CD19 car-t infusion were planned;
- Invasion of central nervous system;
- Pregnant women and lactating women; and female subjects who plan pregnancy within 1 year after cell transfusion or male subjects whose partners plan pregnancy within 1 year after cell transfusion;
- According to the judgment of the researchers, it does not conform to the situation of cell preparation;
- Other researchers think it's not suitable for enrollment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: hCD19 CAR-T cells Infusion
|
Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment. CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10^6/kg. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
BORR
Délai: 6 months
|
Best objective response rate
|
6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence of AE
Délai: 2 years
|
Incidence of adverse reactions
|
2 years
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Pharmacokinetic parameters
Délai: 90 Days
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the area under the curve of 28 days AUC0-28d and 90 days AUC0-90d of targeting CD19 chimeric antigen receptor T cells in peripheral blood after administration
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90 Days
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Overall survival time
Délai: through study completion, an average of 5 year
|
Overall survival time
|
through study completion, an average of 5 year
|
Duration of remission after administration
Délai: through study completion, an average of 5 year
|
Duration of remission after administration
|
through study completion, an average of 5 year
|
Disease progression free survival
Délai: through study completion, an average of 5 year
|
Disease progression free survival
|
through study completion, an average of 5 year
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PG-CART-19-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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