Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's
lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma
(DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as
paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes
transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main
purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell
doses (1-20×20^7 transduced cells/m^2) after lymphodepletion with fludarabine and
cyclophosphamide.