Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
PhasePhase 1/Phase 2
StatusActive, not recruiting
Indication/ConditionAcute Lymphoblastic Leukemia, in Relapse
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
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;