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

NCT04903080 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

HER2 Specific CAR T Cell

HER2 CAR (Chimeric Antigen Receptor) T cells are T cells that have been genetically engineered to target the protein HER2 for the treatment of cancer.

Sponsors & Collaborators

  • Texas Children's Cancer Center

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Meenakshi Hegde, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-27
Primary Completion
2026-06-30
Completion
2043-07-20
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04903080 on ClinicalTrials.gov