Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT

Inclusion criteria

• Children (1-17) and adults (18-75 years old);
• Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
• Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
• Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
• No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
• No longer taking immunosuppressive agents for at least 30 days prior to enrollment;

Exclusion criteria

• Patients with GVHD Grades II-IV;
• Any cell therapy in the last 30 days;