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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

Must not have

Current relevant CNS pathology

Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I have a current brain or spinal cord condition.

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I am currently being treated for or have symptoms of GVHD.

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I am currently fighting a severe infection.

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I have a primary immunodeficiency syndrome.

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I am currently undergoing external beam radiation therapy.

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I am currently on cancer treatment drugs.

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I have no active cancer other than my primary solid tumor.

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

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

Primary study objectives

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 study objectives

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 study objectives

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