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Alkylating agents

CAR T-Cell Therapy + Checkpoint Inhibitors for Sarcoma

Phase 1

Recruiting

Led By Meenakshi Hegde, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Karnofsky or Lansky performance score of ≥ 60

Age between 1 to 25 years

Must not have

Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment

Presence of bulky tumor at the primary or metastatic site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 42 plus/minus 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to give HER2-CAR T cells in combination with pembrolizumab or nivolumab to patients with advanced solid tumors, including sarcomas.

Who is the study for?

This trial is for young patients aged 1-25 with HER2-positive sarcoma, who have normal heart function and organ health. They must not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and have no severe allergies to the drugs used in this study. Patients with certain heart conditions, active infections, HIV or tuberculosis are excluded.

What is being tested?

The trial tests a combination of genetically modified T cells (HER2-CAR T cells) and immune checkpoint inhibitors (pembrolizumab or nivolumab). It aims to see if this mix can safely treat advanced sarcoma by enhancing the body's immune response against cancer after pre-treatment with lymphodepletion chemotherapy.

What are the potential side effects?

Potential side effects include reactions related to CAR T-cell therapy such as fever, fatigue, and low blood cell counts; complications from chemotherapy like nausea; and autoimmune-like symptoms due to checkpoint inhibitors which may cause inflammation in various organs.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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I am between 1 and 25 years old.

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My sarcoma is HER2-positive with a certain level of HER2.

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I have recovered from the side effects of my last cancer treatment.

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My T cells are engineered to target HER2 and are effective against HER2-positive cancer cells.

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My heart's pumping ability is normal.

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My kidney function, measured by creatinine, is within the normal range for my age.

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My HER2 positive sarcoma has worsened or returned after treatment.

Exclusion Criteria

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

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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My cancer has formed a large tumor.

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I have an active case of tuberculosis.

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I have had lung inflammation treated with steroids or have it now.

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I have an immune system disorder or am taking medication to suppress my immune system.

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I have had severe side effects from cyclophosphamide.

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My heart's pumping ability is below normal, or I have severe heart problems.

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I have had severe side effects from fludarabine, such as nerve damage, coma, kidney injury needing dialysis, severe anemia, or a new cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 plus/minus 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~42 plus/minus 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 plus/minus 7 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

ARM A: Dose-limiting toxicity (DLT) rate by CTCAE v5.0. Neurotoxicity and cytokine release syndrome (CRS) will be graded according to ASTCT Consensus Grading System.

ARM B: Dose-limiting toxicity (DLT) rate by CTCAE v5.0. Neurotoxicity and cytokine release syndrome (CRS) will be graded according to ASTCT Consensus Grading System.

Secondary study objectives

Overall Response rate according to RECIST 1.1 Criteria SD, PR and CR are considered responders.