Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells
B-cell Non Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for B-cell Non Hodgkin Lymphoma focused on measuring BTK inhibitor, Anti CD19 CAR-T cells
Eligibility Criteria
Inclusion Criteria: Patients or their legal guardians voluntarily participate and sign the informed consent; Male or female patients aged 18-70 years old; CD19+ B-NHL was confirmed by pathology and histology, and the patient had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Or patients voluntarily chose BTKi+Anti-CD19 CAR T as salvage therapy; Subjects showed residual lesions after major treatment and were not suitable for HSCT; Relapse occurs after CR and is not suitable for HSCT; Patients with high risk factors; Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy; Have measurable or evaluable lesions; The patient's main tissues and organs function well; The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous drip. Patients with ECOG score ≤2, estimated survival time ≥3 months, age ≥ 12 years, ≤ 75 years. Exclusion Criteria: Women who are pregnant (urine/blood pregnancy test is positive) or breastfeeding; Men or women who have planned to get pregnant within the last 1 year; The patients were not guaranteed to take effective contraceptive measures (condom or contraceptive, etc.) within 1 year after enrollment; Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment; Active hepatitis B/C virus; HIV-infected patients; Suffering from a serious autoimmune disease or immunodeficiency disease; The patient is allergic to antibodies, cytokines and other macromolecular biological drugs; The patient had participated in other clinical trials within 6 weeks prior to enrollment; Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); Suffering from mental illness; The patient has substance abuse/addiction; According to the researchers' judgment, the patient had other conditions that were not suitable for inclusion.
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Experimental
CAR-T Cell Infusion
After FC regimen (fludarabine (25mg/m2/d) on days -5 to -3 and cyclophosphamide (750mg/m2) on days -5) were pretreated, Anti-CD19 CAR T cells were transfused on day 0. The dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. Intravenous drip/push at a constant rate for 30 minutes; Ibrutinib, a BTK inhibitor, was enrolled with a standard dose of 560mg qd.