Clinical Study of the Safety and Efficacy of the R/R B-NHL Regimen With BTK Inhibitor+Anti-CD19 CAR-T Cells

To evaluate the ORR (CR+PR) of R/R B-NHL subjects treated with BTKi+Anti-CD19 CAR T cells.

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.