HER2 Specific CAR T Cell for Ependymoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OHEpendymomaHER2 Specific CAR T Cell - Biological
Eligibility
1 - 22
All Sexes
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Study Summary

This trial is testing a new type of immune therapy to see if it is safe and effective against a brain tumor called ependymoma.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 12 Secondary · Reporting Duration: Up to 15 years from the initiation of protocol treatment

Year 2
Overall Survival (OS)
Month 10
Expansion and Persistence of HER2 CAR T Cells at Third Infusion in patients who received this treatment
Month 3
Expansion and Persistence of HER2 CAR T Cells at First Infusion in patients who received this treatment
Percentage of Subjects whose Treatment Delivery Meets Feasibility Criteria
Presence of intra-tumoral HER2 CAR T Cells following First Infusion in Surgical Arm
Month 6
Presence of HER2 CAR T Cells following Second Infusion in Surgical Arm
Month 6
Expansion and Persistence of HER2-CAR T Cells at Second Infusion in patients who received this treatment
Month 7
Therapeutic procedure
Month 9
Expansion and Persistence of HER2-CAR T Cells at Third Infusion in patients who received this treatment
Presence of HER2 CAR T Cells following Third Infusion in Surgical Arm
Year 15
Best Antitumor Response of Infused HER2 CAR T Cells in Surgical Arm
Best antitumor Response of Infused HER2 CAR T Cells in Phase I Arm
Year 2
Event-free Survival (EFS)
Day 42
Upper arm
Number of Subjects with Dose-Limiting Toxicity (DLT) in Surgical Arm

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Treatment (HER2 CAR T cells), Phase I Arm
1 of 2
Treatment (HER2 CAR T cells), Surgical Arm
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: HER2 Specific CAR T Cell · No Placebo Group · Phase 1

Treatment (HER2 CAR T cells), Phase I Arm
Biological
Experimental Group · 1 Intervention: HER2 Specific CAR T Cell · Intervention Types: Biological
Treatment (HER2 CAR T cells), Surgical Arm
Biological
Experimental Group · 1 Intervention: HER2 Specific CAR T Cell · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years from the initiation of protocol treatment

Who is running the clinical trial?

Pediatric Brain Tumor ConsortiumLead Sponsor
36 Previous Clinical Trials
1,260 Total Patients Enrolled
6 Trials studying Ependymoma
287 Patients Enrolled for Ependymoma
Texas Children's Cancer CenterOTHER
7 Previous Clinical Trials
195 Total Patients Enrolled
Baylor College of MedicineOTHER
930 Previous Clinical Trials
5,988,685 Total Patients Enrolled
Meenakshi Hegde, MDStudy ChairBaylor College of Medicine
2 Previous Clinical Trials
53 Total Patients Enrolled

Eligibility Criteria

Age 1 - 22 · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What are the objectives of this experiment?

"The primary assessment over a 42-day period following the initial CAR T cell infusion is to record Patients who experience Dose-Limiting Toxicities (DLT). Secondary criteria for success include the Best Antitumor Response of Infused HER2 CAR T Cells in Surgical Arm and Phase I Arms, which are determined by measuring Complete Responses (CR) or Partial Responses (PR), as well asOverall Survival (OS) calculated from two years after protocol treatment begins." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this experiment still possible?

"Affirmative. Clinicaltrials.gov has evidence to suggest that recruitment for this medical study, first uploaded on July 27th 2022, is still ongoing. The project requires 50 volunteers distributed across 5 sites." - Anonymous Online Contributor

Unverified Answer

What risks are associated with the use of HER2 Specific CAR T Cell therapy?

"Due to the fact that HER2 Specific CAR T Cell is in its initial testing stage, there are limited clinical findings verifying efficacy and safety. So, our team at Power provisionally scored it a 1 on the scale from 1-3." - Anonymous Online Contributor

Unverified Answer

How many individuals are partaking in this clinical investigation?

"Affirmative. According to the data available on clinicaltrials.gov, this clinical trial commenced recruitment activities on July 27th 2022 and is still active as of November 15th 2022. The study necessitates 50 participants from 5 distinct sites." - Anonymous Online Contributor

Unverified Answer

Are there any other sites participating in this experimental protocol within the city?

"This study is being administered at Pittsburgh Children's Hospital of UPMC, Cincinnati Children's Hospital Medical Center, and Ann & Robert H. Lurie Children's Hosptial in Chicago as well as five other clinical sites." - Anonymous Online Contributor

Unverified Answer

Is this research recruiting participants aged 70 or older?

"Eligibility for this medical experiment is only open to persons aged 1 year through 22 years old. Additionally, 47 clinical trials are available for minors and 10 such studies exist for seniors." - Anonymous Online Contributor

Unverified Answer

What criteria must a participant fulfill to be accepted into this research endeavor?

"Individuals diagnosed with ependymoma, aged between 1 and 22 years old, are welcome to apply for this clinical trial. Approximately 50 candidates need to be recruited in total." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.