Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04903080 · ClinicalTrials.gov registry record · Phase 1
HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma
A Phase 1 study of Ependymoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 13
- Study locations
NCT04903080: Active Phase 1 study of Ependymoma, sponsored by Children's Oncology Group.
NCT04903080 is a Phase 1 study of Ependymoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 50 participants, below the 102-participant average among 20 other Ependymoma trials with a reported enrollment target (51% lower). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04903080, a Phase 1 study of Ependymoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
DLT is defined as an adverse event that is at least possibly attributed to the investigational agent (HER2 CAR T cells) that occurs during the dose-finding period (the first 42 days following the first CAR T cell infusion) regardless of expectedness with a few exceptions, for which Section 6.4 of the protocol provides more details. All patients in Safety/Feasibility cohort who received at least 1 dose of HER2 CAR T cells are included in the assessment.
Conditions Studied
Interventions
- BIOLOGICAL HER2 Specific CAR T Cell
Study Locations (13)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Florida - Gainesville
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2043-07-20 |
| Phase | Phase 1 |
What the registry record for NCT04903080 still lists
NCT04903080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 102-participant average among 20 other Ependymoma trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Ependymoma appearing as the primary indexed condition, and to 1 intervention - of which HER2 Specific CAR T Cell is the first listed.
NCT04903080 lists 13 locations in 12 states (Ohio, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT04903080 about?
NCT04903080 is a clinical study titled "HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma". 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 ba...
What is the current status of trial NCT04903080?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-07-27. Estimated completion is 2043-07-20.
What conditions does trial NCT04903080 study?
This clinical trial studies the following conditions: Ependymoma.
What interventions are being tested in trial NCT04903080?
The interventions under investigation include: HER2 Specific CAR T Cell (BIOLOGICAL).
Who is sponsoring clinical trial NCT04903080?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04903080 being conducted?
This trial has 13 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ependymoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04903080's enrollment target sits among peer trials
50 12th of 20 higher than 9 of 20 other Ependymoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ependymoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors
RECRUITING · Phase 1
-
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
RECRUITING · Phase 1
-
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
RECRUITING · Phase 1
-
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
RECRUITING · Phase 1
-
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
RECRUITING · Phase 1
-
LET Optimized IMPT in Treating Pediatric Patients With Ependymoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI