Extrait

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) with a safety switch will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy. Objectives: To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for patients with B cell malignancies. Eligibility: Patients between 1 and 85 years of age, who have relapsed or refractory CD19-expressing B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments. Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria are eligible to participate. Patients must have adequate organ functions. Design: - Peripheral blood from patients will be collected for isolation of peripheral blood mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector encoding anti-CD19 CAR containing a CD28 and a CD3 zeta as costimulatory domains as well as a safety switch. - Patients will receive a lymphodepleting preconditioning regimen to prepare their immune system to accept modified T cells. - Patients will receive an infusion of their own modified T cells. They will remain in the hospital to be monitored for adverse events until they have recovered from the treatment. - Patients will have frequent follow-up visits to monitor the persistence of modified T cells and efficacy of the treatment.

Critère d'inclusion

• Chronic lymphocytic leukemia,Acute Lymphocytic Leukemia,LYMPHOMA

Liens

• ictrp
• nct