study evaluating the efficacy and safety with car-t immunotherapy for cd19 positive lymphoma

Conditions: Lymphoma

Summary: this open, single-arm,multicenter 2 phase clinical study will treat the patient who have cd19 positive lymphoma with an infusion of the patient's own t cells that have been genetically modified to express a chimeric antigen receptor(car)that will bind to tumour cells modified to express the cd19 protein on the cell surface. the study will determine if these modified t cells help the body's immune system eliminate tumour cells .the trial will also study the safety of treatment for car-t, how long car-t cells stay in the patient's body and the impact on this treatment for survival.

this is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor t cell immunotherapy (car-t) in the treatment of cd19 positive lymphoma. the study will be conducted using a phaseⅰ/ⅱdesign the study will have the following sequential phases: part a (screening, leukapheresis, cell product preparation and cytoreductive chemotherapy) and part b (treatment and follow-up). the follow-up period for each participant is approximately 35 months after the final car-t infusion. the total duration of the study are expected to be approximately 3 years. a total of 24 patients may be enrolled over a period of 3 years.

Eligibility criteria:
inclusion criteria: * 1.age older than 16 years old,gender and race no limited. * 2.pathological diagnosis of cd19 express positive recurrent or refractory b lymphoma, satisfy any of the following a diagnosis of recurrent or refractory lymphoma: (1) according to the standard solution standardization more than four courses of treatment, tumor size \< 50% or progression;(2) according to the standard solution treatment of complete remission, after recurrence again with the original plan or the national expert consensus recommended second-line cannot again get to complete remission (3) relapse after hematopoietic stem cell transplantation. * 3.patients into the group needs lesions to be available for testing or evaluating disease. * 4.ecog score reaches 0 to 1 points. * 5.patients into the group of white blood cell counts in peripheral blood acuity≥ 1.0 x10\^9 / l. * 6.estimated survival times \> 90 days. * 7.patients have self-knowledge ability, can sign the informed consent form. exclusion criteria: * 1.pregnant or lactating women. * 2.uncontrolled infection. * 3.hiv infection, hepatitis b or c activity period. * 4.patients who need long-term immunosuppressive therapy (such as allergies, autoimmune diseases, gvhd, etc.) * 5.combined activity of the central nervous system malignant tumor invasion. * 6.abnormal coagulation function, patients with severe thrombosis. * 7. organ failure heart：class ⅱ or above. liver：class ⅱ or above( refer to classification of wuhan conference (1983)). kidney: the second stage of renal insufficiency or above. lung: class ⅱdecreased slightly or above. brain: the central nervous system transfer or have active lesions. * 8.patients who have participated in other clinical trials in the past 30 days or or participate in other clinical trials at the same time. * 9.investigator believe that the patient is not suitable to participate in the study.

Keywords: cd19 positive lymphoma