B7-H3 CAR T Cell Therapy for Pediatric Brain Tumors
This study aims to evaluate the feasibility and safety of delivering B7-H3 CAR T cell therapy directly into the brain of children with brain tumors.
SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel
Diffuse Intrinsic Pontine Glioma+21
+ Brain Diseases
+ Brain Neoplasms
Treatment Study
Summary
Study start date: December 11, 2019
Actual date on which the first participant was enrolled.This study focuses on testing a new type of treatment for children and young adults with specific types of brain tumors, known as diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and certain recurrent or difficult-to-treat central nervous system tumors. The treatment involves using a patient's own T cells, a type of immune cell, which are specially modified to attack cancer cells that have a specific marker called B7H3. This study aims to see if enough of these modified T cells can be made and safely given to patients directly into the brain through a special tube. This approach is important because it might offer a new way to target and treat these challenging brain tumors directly at the site. Participants in the study will undergo a process where their T cells are collected and then engineered in a lab to recognize and attack the tumor cells. The treatment is given in two courses, with the T cells being delivered into the brain either into the space where the tumor was removed or through the ventricular system, depending on the type and location of the tumor. There are three different treatment plans based on these factors. The study will closely monitor the safety of this treatment by tracking any side effects and measuring how the T cells move and interact with the body. MRI scans and other tests will be used to evaluate the treatment's effect on the tumor, and patients might continue receiving the treatment if it is well-tolerated and beneficial.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 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 26 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.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary 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