Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed/Refractory B Cell Lymphoma
To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse / refractory B cell lymphoma
• Age 18-75 years old, no gender limit;
• Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
∙ Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ;
‣ Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;
‣ Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;
• Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
• At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
• The expected survival period is ≥12 weeks;
• The puncture section of the tumor tissue was positive for CD19 expression;
• ECOG score 0-2 points;
• Sufficient organ function reserve:
∙ Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
‣ Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
‣ Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
‣ Glomerular filtration rate\>50Ml/min
‣ Cardiac ejection fraction (EF) ≥50%;
‣ Under natural indoor air environment, basic oxygen saturation\>92%
• Allow a previous stem cell transplantation
⁃ The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;
⁃ Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;
⁃ Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial
⁃ Two tests for the new coronavirus or swine flu virus are negative.