CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.
• Eligible disease conditions:
‣ Relapsed or refractory B-cell ALL (all must be satisfied)
• Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.
∙ Relapsed or refractory or ineligible for HSCT
∙ For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry
⁃ Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
• Age at screening:
‣ \< 18 years (paediatric group); or
⁃ ≥ 18 years (adult group)
• Adequate organ functions:
• Life expectancy more than 12 weeks.
• Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening.
• Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.