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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

Must not have

History of any lymphoproliferative disorder

Patients receiving any other anti-cancer or investigational drug therapy

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where lymphocytes are produced in excessive amounts.

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I am not on any other cancer treatments or experimental drugs.

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I do not have an active autoimmune disease, uncontrolled infection, or major heart problems.

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I have a history of cancer.

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My scans show I have large tumors.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Upper arm

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

Percentage of Subjects whose Treatment Delivery Meets Feasibility Criteria

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 8Eligibility criteria met