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CAR T-cell Therapy

Cell Therapy for Relapsed/Refractory Head and Neck Cancer

Phase 1 & 2

Recruiting

Led By Jared Weiss, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky score of > 60%

Histologically or cytologically confirmed stage recurrent/metastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.

Must not have

Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment to see if it is safe and tolerable for patients with head and neck cancer that came back after standard therapy. Blood will be taken to make the treatment, which will then be infused and studied for side effects.

Who is the study for?

This trial is for adults over 18 with recurrent/metastatic squamous cell carcinoma of the head and neck, who have a Karnofsky score above 60%, indicating they can care for themselves. It's not open to those with severe heart disease, recent stroke or TIA, or allergies to cyclophosphamide or fludarabine.

What is being tested?

The study tests autologous CAR-T cells targeting CSPG4 in patients whose head and neck cancer returned after standard treatment. The safety and tolerable dose levels are being determined. Patients will undergo lymphodepletion chemotherapy before receiving the experimental iC9.CAR-CSPG4 T cell infusion.

What are the potential side effects?

Potential side effects include reactions related to immune system activation by CAR-T cells such as fever, fatigue, blood pressure changes, and breathing difficulties; plus typical chemotherapy side effects like nausea, hair loss, mouth sores, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself.

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My cancer is a type of squamous cell carcinoma in the head or neck area.

Exclusion Criteria

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

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I do not have severe heart problems like uncontrolled high blood pressure or recent heart attacks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose Limiting Toxicity

Toxicity: Cytokine Release Syndrome (CRS)

Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)

+1 more

Secondary study objectives

Objective response rate

The recommended phase 2 dose (RP2D) of iC9-CAR.CSPG4

Other study objectives

Duration of Response (DOR)

Feasibility of iC9-CAR.CSPG4 T cell therapy

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chimeric Antigen ReceptorsExperimental Treatment3 Interventions

blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease-fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cell Therapy

2016

Completed Phase 3

~180

Cyclophosphamide

2010

Completed Phase 4

~2310