cd19 car t cells in patients with relapsed or refractory cd19 positive b-cell lymphoma

Conditions: Lymphomas Non-Hodgkin's B-Cell; Relapse

Summary: in this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory cd19 positive b-cell non-hodgkin lymphoma (nhl) patients will be enrolled.cd19 car t cells(total dose of 2×10\^6/kg-1×10\^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. the purpose of current study is to determine the clinical efficacy and safety of cd19 car t cells in patients with relapsed or refractory cd19 positive b-cell lymphoma.

in this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory cd19+ b-cell non-hodgkin lymphoma (nhl) patients will be enrolled. cd19 car t cells transduced with a lentiviral vector to express anti-cd19 scfv tcrζ:4-1bb, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. side effects of cd19 car t cells therapy will be monitored. the purpose of current study is to determine the clinical efficacy and safety of cd19 car t cells therapy in patients with relapsed or refractory cd19 positive b-cell lymphoma.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 70 years with relapsed or refractory cd19 positive b-cell lymphoma. * eastern cooperative oncology group (ecog) performance status 0-2. * adequate end organ function as defined by: total bilirubin ≤ 1.5 x upper limit of normal（uln）; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 x uln; creatinine ≤ 1.5 x uln or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min. * male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study. * patients should sign informed consent form. exclusion criteria: * patients with central nervous system involvement by lymphoma. * prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load. * prior allogeneic hematopoietic stem cell transplant (hsct) ≤ 4 months before enrollment. patients must have completed immunosuppression therapy prior to enrollment. at enrollment, patients must not have≥ grade 2 acute gvhd, or either moderate or severe limited chronic gvhd, or extensive gvhd of any severity. * known systemic vasculitides, primary or secondary immunodeficiency(such as hiv infection or severe inflammatory disease). * major surgery within 4 weeks before enrollment. * impaired cardiac function:ejection fraction ≤45 % on muga scan. qtc interval \> 450msecs on baseline ecg. myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias). * administration of live vaccine ≤ 4 weeks before enrollment. * other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.

Keywords: lymphoma non-hodgkin b-cell cd19 car t cells refractory relapse