A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL.
Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Age≥18 years old，gender is not limited;
Expected survival > 12 weeks;
ECOG score 0-2;
B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);
Malignant tumors other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL) within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;
Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and positive peripheral blood hepatitis B virus (HBV) DNA titers (higher than the upper limit of the normal range of the investigative site); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis positive;
Any uncontrolled systemic diseases, including but not limited to active infection (except for localized infection), uncontrolled angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
Any other uncontrolled active disease that precludes participation in the trial;
Single group
Human CD19Targeted T Cells Injection
DrugA single dose of predetermined level CAR-positive T cells will be infused.
Overall response rate (ORR) at 3 months post infusion
ORR is defined as proportion of subjects who achieved Partial remission(PR) or better at 3 months (D90±7) post infusion as assessed by an independent review committee (IRC) based on Lugano 2014 criteria.
Duration of remission (DOR) after administration
DOR refers to the time from the first assessment of complete response or partial response to the first assessment of disease progression or death from any cause.
Progression-free Survival (PFS) after administration
PFS refers to the time from the start of cell infusion to the first assessment of tumor progression or death from any cause.
Overall Survival (OS) after administration
OS refers to the time from cell infusion to death due to any cause.
Disease control rate (DCR)
The best overall response is the ratio of partial response(PR) or complete response(CR) or stable disease(SD) patients to the total number of cases.
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Hrain Biotechnology Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
