Study of CD19 CAR-T Cell Therapy for Children Aged 1 to 17 with Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoma

What this Trial Is About

Researchers are studying the safety and effectiveness of using a special type of modified immune cell called CD19-CAR T cells in children aged 1 to 17 years who have relapsed or refractory acute lymphoblastic leukemia ALL or lymphoma. These immune cells are designed to target a protein called CD19 found on cancer cells. The study aims to confirm the safety of this treatment and observe how well it works in these children after they have received chemotherapy to prepare their bodies. Participants will receive a single intravenous infusion of CAR-T cells at a dose based on their body weight, following a chemotherapy regimen to reduce immune cells and help the CAR-T cells work better. This treatment is given once during the study, and the children are closely monitored afterward. The study is sponsored by Hong Kong Childrens Hospital and does not include a placebo or comparison group. During the study, children will have regular assessments including blood tests to measure response to treatment, scans to track disease status, and checks for side effects. The main outcomes measured are the complete response rate for ALL within one month and overall response rate for lymphoma within three months. Safety is monitored throughout an average follow-up period of six months, with additional assessments of survival and treatment success up to one year. Participation involves visits for evaluation, treatment, and follow-up over this time frame.

CD-19 CAR-T Cell for Pediatric ALL or Lymphoma