Overview
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following:
- What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)?
- What is the rate of Event-free survival at first month and 2-3 months after intervention?
- What is the rate of Overall survival at first month and at 3 months after the intervention?
Description
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.
Eligibility
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