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CAR T-cell Therapy

CAR T Cell Therapy for Pediatric Solid Cancers

Phase 1

Recruiting

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Subsequent subjects: age ≥ 1 and ≤ 30 years

Histologically diagnosed malignant, non-CNS solid tumor expressing EGFR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

Study Summary

This trial is testing genetically-modified T cells to treat solid tumors in children and young adults. The goal is to evaluate safety and feasibility, and to determine if the cells can kill tumors.

Who is the study for?

This trial is for children and young adults aged 1-30 with certain non-CNS solid tumors that are recurrent or resistant to treatment. Participants must have a life expectancy of at least 8 weeks, be able to undergo apheresis (a procedure to collect immune cells), and not have had recent myeloablative therapy unless they've recovered. They should not be receiving other cancer treatments or have active infections, CNS pathology, GVHD, primary immunodeficiency, or be pregnant.Check my eligibility

What is being tested?

The study tests genetically modified T cells designed to target EGFR on tumors in two groups: one receives CAR T cells targeting only EGFR; the other targets both EGFR and CD19. The goal is to see if these T cells are safe, can be made successfully from participants' blood, what dose is tolerated best without severe side effects (except manageable ones like cytokine release syndrome), how long they last in the body, and their effectiveness against tumors.See study design

What are the potential side effects?

Potential side effects include reactions related to the infusion of modified T cells such as cytokine release syndrome which can cause fever and flu-like symptoms. There's also a risk of organ inflammation due to an immune response by the engineered T cells. If serious toxicities occur beyond what's manageable with standard care, cetuximab or trastuzumab may be used as 'suicide switches' to eliminate the problematic T cells.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 30 years old.

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My cancer is not in the brain and tests positive for EGFR.

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I can undergo apheresis or have apheresis material ready for use.

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I can do most activities but need help with some.

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My condition has not improved or has returned after treatment.

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It's been over 30 days or 3 half-lives since my last antibody cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Establish the safety, defined by adverse events, of EGFR806-specific CAR T cell infusions (Arm A), and of dual transduced EGFR806xCD19 CAR T cell infusions (Arm B)

Estimate the maximum tolerated dose (MTD) or biologically effective dose and dose limiting toxicities (DLT), and describe the full toxicity profile of the two CAR T cell products

The number of successfully manufactured EGFR806 and EGFR806xCD19 CAR T cell products will be assessed

Secondary outcome measures

Number of Arm A and Arm B subjects with persistence of CAR T cells in the bone marrow at each visit time point

Number of Arm A and Arm B subjects with persistence of CAR T cells in the peripheral blood at each visit time point

Other outcome measures

To quantitate anti-tumor responses by measuring changes in tumor burden using disease-specific evaluations and describe survival characteristics following CAR T cell infusion

Trial Design

2Treatment groups

Experimental Treatment

Group I: EGFR806CAR(2G)-EGFRt and CD19CAR(2G)-T2A-HER2tGExperimental Treatment1 Intervention

Autologous CD4+ and CD8+ T cells that have been genetically modified to express the EGFR806CAR(2G)-EGFRt and CD19CAR(2G)-T2A-HER2tG

Group II: EGFR 806CAR(2G) -EGFRtExperimental Treatment1 Intervention

Autologous CD4+ and CD8+ T cells that have been genetically modified to express the EGFR 806CAR(2G) -EGFRt

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,680 Total Patients Enrolled

5 Trials studying Germ Cell Tumors

271 Patients Enrolled for Germ Cell Tumors

Katie Albert, MDStudy ChairSeattle Children's Hospital

Media Library

EGFR806 CAR T Cell Immunotherapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03618381 — Phase 1

Germ Cell Tumors Research Study Groups: EGFR 806CAR(2G) -EGFRt, EGFR806CAR(2G)-EGFRt and CD19CAR(2G)-T2A-HER2tG

Germ Cell Tumors Clinical Trial 2023: EGFR806 CAR T Cell Immunotherapy Highlights & Side Effects. Trial Name: NCT03618381 — Phase 1

EGFR806 CAR T Cell Immunotherapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03618381 — Phase 1

Frequently Asked Questions

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

Is this research study accommodating elderly participants aged 85 or older?

"Eligibility for this clinical trial requires that participants fall within the age range of 1 Year to 30 Years old. There are 675 studies intended for individuals below 18, and 4856 specifically designed for those over 65 years."

Answered by AI

How many participants does this research endeavor require?

"Affirmative, the data hosted on clinicaltrials.gov shows that this medical experiment is currently enrolling participants. This research initiative was initially posted June 18th 2019 and has been most recently edited May 2nd 2022. The investigation is seeking to recruit 36 patients from one site."

Answered by AI

Are there any vacancies available for those wishing to participate in the trial?

"The clinical trial is still enrolling participants, as indicated on the information hosted on clinicaltrials.gov. The study was first posted to the site in June of 2019 and has been updated most recently in May 2022."

Answered by AI

Has the 4-1BBζ EGFR806-EGFRt formulation obtained FDA sanction?

"With limited data available on safety and efficacy, our team at Power has rated the second generation 4-1BBζ EGFR806-EGFRt a 1 in terms of its security."

Answered by AI

Am I eligible to be a subject in this research endeavor?

"The clinical trial is accepting a cohort of 36 participants between the ages of 1 Year and 30 with wilms tumor. Eligible candidates must also have an acceptable Lansky or Karnofsky score, be able to tolerate apheresis/have viable apheresis products for use in manufacturing, evidence of refractory or recurrent disease, at least 8 weeks remaining in their life expectancy, recovered from prior chemotherapy/biologic therapy toxic effects within 7 days post administration (or 3 half-lives if no product available), and not received any anti-tumor antibody therapies within the last thirty days."

Answered by AI