Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL

B-cell acute lymphoblastic leukemia (B-ALL), as the most common type of pediatric tumor, is identified by unregulated cell proliferation of immature lymphoid cells that can infiltrate the bone marrow and blood. Also, relapse and refractory B-ALL (R/R B-ALL) is the main reason of global mortality due to the constraints of combination chemotherapy.

Over the past few years, substantial advancements have been made in treatment of ALL, specifically in the R/R context. Chimeric antigen receptor T (CAR-T) cells are a type of cancer immunotherapy treatment that function through modification of patient T cells to express CAR antigen on their surface. CAR-T cells aimed at CD19 have demonstrated promising activity in treatment of r/r B-ALL. In this study we aim to evaluate safety and efficacy of Anti-CD19 CAR T cell therapy in children with R/R B-ALL.

Inclusion criteria

• Ages 2 to 18 years with relapsed or refractory CD19+ B-ALL
• Presence of disease in the bone marrow
• Able to tolerate the apheresis process
• Life expectancy > 12 weeks
• Lansky or Karnofsky score > 50%
• At least 7 days passed since the last chemotherapy and the last treatment with corticosteroids
• Informed consent
• Having potential donor for stem cell transplantation

Exclusion criteria

• Presence of active malignancy other than the disease under study
• Chloroma and leukemic infiltration on MRI or significant neurological symptoms
• Any CNS disorder
• Presence of active GVHD
• Radiation therapy within last 14 days
• History of Anti-CD19 or Anti-CD20 therapy
• Donor lymphocyte injection or other cell therapy methods within the last 30 days
• Presence of severe active infection
• Organ dysfunction