CD19/CD22 CAR-T Cell Therapy for Children with MRD-Positive B-ALL
CAR-T Therapy
Hematologic Diseases+8
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: October 1, 2024
Actual date on which the first participant was enrolled.This study focuses on testing a new treatment called CAR-T cell therapy for children with a type of blood cancer known as B-lineage Acute Lymphoblastic Leukemia (B-ALL). Specifically, it targets those who still show signs of the disease after initial treatment, known as MRD-positive. The aim is to see if this treatment is safe and effective for these children, as current options might not fully eliminate cancer cells. Successful outcomes could lead to better treatment strategies for these young patients, potentially improving survival rates and quality of life. Participants in the study undergo a series of steps, starting with an initial screening to ensure they meet the criteria for treatment. After consenting, the child's own white blood cells are collected and modified in a lab to create CAR-T cells that target cancer cells. Before receiving the CAR-T cells through an intravenous infusion, participants undergo a preparatory treatment to reduce existing lymphocytes, using medications such as fludarabine and cyclophosphamide. The effectiveness of the treatment is assessed through tests measuring remaining cancer cells. Participants are closely monitored for side effects like CRS and ICANS, with follow-ups occurring frequently in the first month, gradually reducing to yearly check-ins over several years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Guangzhou Medical University Affiliated Women and Children's Medical Center
Guangzhou, ChinaOpen Guangzhou Medical University Affiliated Women and Children's Medical Center in Google Maps