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CAR T-cell Therapy

CAR T Cell Therapy for Ependymoma

Phase 1

Recruiting

Research Sponsored by Pediatric Brain Tumor Consortium

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have received standard of care therapy including maximal safe surgical resection followed by local adjuvant radiation therapy prior to enrollment

Patient must have a diagnosis of ependymoma that is recurrent or progressive with histologic verification

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years from the initiation of protocol treatment

Awards & highlights

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.

Who is the study for?

This trial is for children aged 1 to 21 with recurrent or progressive ependymoma, a type of brain tumor. They must have had standard treatments and be HER2-positive. Kids need to be in good enough health with stable neurological conditions and not on other cancer treatments.Check my eligibility

What is being tested?

The study tests HER2 CAR T cells, which are the patient's own immune cells genetically modified to attack their tumor by recognizing a protein called HER2. It aims to see how safe this treatment is and how well it works against ependymoma in kids.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells, infusion-related reactions, fatigue, fever, headache, drops in blood pressure, nausea, vomiting, breathing difficulties and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had surgery and radiation for my condition as standard treatment.

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My ependymoma cancer has come back or is getting worse, confirmed by tests.

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I have enough tumor samples for HER2 testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years from the initiation of protocol treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years from the initiation of protocol treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years from the initiation of protocol treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Upper arm

Number of Subjects with Dose-Limiting Toxicity (DLT) in Surgical Arm

Percentage of Subjects whose Treatment Delivery Meets Feasibility Criteria

Secondary outcome measures

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

Event-free Survival (EFS)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (HER2 CAR T cells), Surgical ArmExperimental Treatment1 Intervention

Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1. Patients receive HER2 CAR T cells IV on Day 0 followed by surgical tumor resection 4-6 weeks following HER2 CAR T cell infusion. Treatment repeats every 8 to 15 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity.

Group II: Treatment (HER2 CAR T cells), Phase I ArmExperimental Treatment1 Intervention

Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1. Patients receive HER2 CAR T cells IV on Day 0. Treatment repeats every 8 to 12 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN

8 Previous Clinical Trials

635 Total Patients Enrolled

4 Trials studying Ependymoma

447 Patients Enrolled for Ependymoma

National Cancer Institute (NCI)NIH

13,661 Previous Clinical Trials

40,924,372 Total Patients Enrolled

81 Trials studying Ependymoma

8,830 Patients Enrolled for Ependymoma

Pediatric Brain Tumor ConsortiumLead Sponsor

37 Previous Clinical Trials

1,532 Total Patients Enrolled

7 Trials studying Ependymoma

574 Patients Enrolled for Ependymoma

Media Library

HER2 Specific CAR T Cell (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04903080 — Phase 1

Ependymoma Research Study Groups: Treatment (HER2 CAR T cells), Surgical Arm, Treatment (HER2 CAR T cells), Phase I Arm

Ependymoma Clinical Trial 2023: HER2 Specific CAR T Cell Highlights & Side Effects. Trial Name: NCT04903080 — Phase 1

HER2 Specific CAR T Cell (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903080 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903080.

All > Ependymoma