B-cell lymphoma
Conditions
Interventions
experimental group:B6I-28Z CAR-T
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: [1] Age 18-70 years old (including the threshold), gender, race; [2] Patients or their legal guardians voluntarily participate and sign informed consent; [3] Expected survival >12 weeks; [4] The expression of CD19 in tumor cells must be confirmed by pathology or immunohistochemistry. [5] Hematological malignancies of recurrent or refractory B-cell origin (including but not limited to diffuse large B-cell lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/small gonocytic lymphoma, follicular lymphoma, marginal zone lymphoma, etc.); [6] Patients currently have no effective treatment options, such as relapse or disease remission after chemotherapy, hematopoietic stem cell transplantation or autologous cell immunotherapy; Or patients voluntarily choose to receive transfusions of CD19-targeting B6I-28Z CAR T cells as salvage therapy; [7] Patients should be admitted with relevant indicators that can be used to detect or evaluate the disease within 4 weeks after the last treatment, such as CT showing target lesion (lymph node) LDi (longest transverse diameter) =1.5cm, PET-CT showing target lesion (lymph node) with SUV taking value exceeding liver blood pool, bone marrow MRD showing abnormal B cells (such as bone marrow metastasis), etc. [8] Quality of life score (KPS) >50%; [9] The patient had no serious heart, liver, or kidney disease. Cardiac function: left ventricular ejection fraction greater than or equal to 40%; ALT and AST< 3 times the normal value; Bilirubin < 2.0mg/dl; Serum creatinine =1.6mg/dl and/or urea nitrogen =1.5mg/dl; [10] The patient's peripheral superficial vein has smooth blood flow, which can meet the needs of intravenous infusion. [11] are not suitable for stem cell transplantation conditions or give up transplantation due to conditions limitations;
Exclusion criteria
Exclusion criteria: [1] Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months; [2] Infectious diseases (such as HIV, active tuberculosis, etc.); [3] Active hepatitis B or C infection; [4] An absolute neutrophil count of <0.75×10^9/ l or a platelet count of <50×10^9/ l is not due to primary disease [5] Abnormal vital signs and failure to cooperate with examinations; [6] Persons with mental or mental illness who cannot cooperate with treatment and evaluation of efficacy; [7] High allergy or history of severe allergy; [8] Subjects with systemic infection or local severe infection requiring anti-infection treatment; [9] Any of the following: a) Platelet transfusion within 1 week before enrollment; b) Red blood cell (RBC) transfusion within 2 weeks prior to enrollment; c) The following blood growth factors were administered during the first 2 weeks of enrollment: granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), erythropoietin (EPO), megakaryocyte growth factor, and/or platelet stimulating factor. [10] Subjects with severe autoimmune diseases; [11] Primary central nervous system lymphoma or lymphoma invading the central nervous system; [12] Doctors believe that there are other reasons for not being included in the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Total remission rate;Complete remission rate;Partial remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival ; | — |
Countries
China
Contacts
Public ContactCao Jiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed