ACTIVE_NOT_RECRUITING

HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase I study to evaluate the safety profile of a type of immune therapy called HER2 CAR T cells (short for HER2 chimeric antigen receptor T cells). In addition to looking for side effects, we will study how well this treatment works against a brain tumor called ependymoma that has come back after treatment (recurrent) or has not responded well to treatment (progressive) in children. The HER2 CAR T cells used in this trial are made from the patient's own blood. A new gene, called the HER2 CAR, will be inserted into patient's T cells to allow them recognize a protein on the tumor called HER2. These HER2-specific CAR T cells may be able to target and kill ependymoma tumors that express HER2. This research is also studying how doable it is to provide this type of CAR T cell treatment to children being treated at different hospitals.

Official Title

Phase 1 Trial of Autologous HER2-specific CAR T Cells in Pediatric Patients With Refractory or Recurrent Ependymoma

Quick Facts

Study Start:2022-07-27
Study Completion:2043-07-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04903080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Meenakshi Hegde, MD
STUDY_CHAIR
Baylor College of Medicine

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90026
United States
Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010
United States
University of Florida
Gainesville, Florida, 32608
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Pittsburgh Children's Hospital of UPMC
Pittsburgh, Pennsylvania, 15224
United States
Texas Children's Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Pediatric Brain Tumor Consortium

  • Meenakshi Hegde, MD, STUDY_CHAIR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-27
Study Completion Date2043-07-20

Study Record Updates

Study Start Date2022-07-27
Study Completion Date2043-07-20

Terms related to this study

Additional Relevant MeSH Terms

  • Ependymoma