cd19 car t-cell therapy for r/r non-hodgkin lymphoma and acute lymphoblastic leukemia

Conditions: B-Cell Non Hodgkin Lymphoma; B-Cell Acute Lymphoblastic Leukemia

Summary: * brief summary: cluster of differentiation 19 (cd19) is expressed on b cells. cd19+ tumor cells in patients with non-hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using t cells expressing cd19-specific chimeric antigen receptor (car). * objective: this study aims to evaluate the safety and efficacy of single-dose anti-cd19 car t-cell therapy in the treatment of relapsed/refractory cd19+ non-hodgkin lymphoma and acute lymphoblastic leukemia. * eligibility: people aged 1 to 60 years with relapsed/refractory cd19+ non-hodgkin lymphoma and acute lymphoblastic leukemia. * design: phase 1 clinical trial, uncontrolled, single dose of cd19 car t-cells.

objectives: * evaluate the frequency and severity of adverse events and serious adverse events (aes/saes) of the therapy. * evaluate the response rate after cd19 car t-cell infusion according to the following criteria: * proportion of patients with complete response and partial response after cd19 car t-cell infusion * progression-free survival (pfs) after infusion of cd19 car t-cells * event-free survival (efs) after infusion of cd19 car t-cells * overall survival (os) after infusion of cd19 car t-cells

Eligibility criteria:
inclusion criteria: * b-cell acute lymphoblastic leukemia: refractory to two cycles of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation. * b-cell non-hodgkin lymphoma: refractory to two lines of chemotherapy, relapsed after chemotherapy, or hematopoietic stem cell transplantation. * age: from 1 to 60 years old (both males and females) * adequate organ functions: * serum creatinine ≤ 1.5 x uln or egfr ≥ 60 ml/min/1.73 m2 * alt and ast ≤ 5 x uln; bilirubin ≤ 2.0 mg/dl * no chronic lung diseases, such as obstructive pulmonary disease or bronchial asthma, required continuous medications without respiratory failure (spo2 oxygen saturation \> 92% at room temperature). * no arrhythmia, no intracardiac thrombus or vascular wall, no heart failure, lvef ≥ 45% * blood test: * absolute neutrophil count (anc) ≥ 1,000/mm3 (1 g/l) without filgrastim * absolute lymphocyte count ≥ 100/mm3 (0.1 g/l) * absolute platelet count ≥ 75,000/mm3 (75 g/l) * hemoglobin ≥ 8.0 g/dl * positive for cd19 measured by immunohistochemistry or flow cytometry. * agree to participate in the study * agree to use safe methods of contraception for female patients. exclusion criteria: * involved central nervous system invasion at the time of screening. * medical history of veno-occlusive disease (vod). * required acute treatment due to tumors such as intestinal obstructions, vascular compression, or respiratory failure. * having active hemolytic anemia. * diagnosed with primary immunodeficiency. * medical history of autoimmune neurological diseases or neuromyelitis. * receiving immunosuppressive medication, except for ≤ 30 mg prednisolone or equivalent at the time of car-t-cell transfusion. * having acute, progressive, or chronic graft-versus-host disease (gvhd). * having active infectious diseases determined by clinical, imaging, or other laboratory tests (blood culture, pcr, etc.) * patients who are critically ill or at risk of premature death characterized by: * acute liver failure requiring dialysis * heart failure requiring vasopressors * systemic infection unresponsive to antibiotics * ecog performance status ≥ 3 points at the time of screening * having other severe concomitant diseases (e.g., uncontrolled arterial hypertension, heart failure nyha iii-iv). * unstable angina within 3 months prior to screening. * any previous or concurrent malignancy was not b-cell lymphoma or b-all. * medical history of clinically relevant central nervous system disease, such as epilepsy, convulsions, paralysis, aphasia, uncontrolled cerebrovascular disease, traumatic brain injury, and parkinson's disease. * intolerance to excipients from cellular products. * pregnant women or those who expect to be pregnant or reastfeeding. * other diseases or other conditions and circumstances that, according to the investigator's assessment, make it difficult to ensure compliance with study treatment. * participation in another clinical trial at the time of screening