Recruiting
Phase 1

CAR-T Cells

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06096038

Conditions

Head and Neck Cancer

Relapse

Recurrent

Refractory Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Fludarabine

Cell Therapy

Study Details

Brief summary:

The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.

How many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.

There are two parts to this study. In part 1, 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.

The data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.

Eligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.

Conditions

Head and Neck Cancer

Relapse

Recurrent

Refractory Cancer

Study ID

NCT06096038

Start date

Apr 5, 2024

Status verified date

Jul, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:

1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of > 60%
4. 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.

Exclusion Criteria:

1. 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.
2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.
3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.

Study Design

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chimeric Antigen Receptors

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.

Interventions

Cyclophosphamide

cyclophosphamide 300 mg/meter square IV

Fludarabine

fludarabine 30 mg/meter square IV × 3 days

Cell Therapy

the autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen iC9-CAR.CSPG4 T cell infusion iC9-CAR.CSPG4 T cell infusion

Primary outcome measure

  • Toxicity: NCI-CTCAE [ Time Frame: Up to 4 weeks ]
  • Toxicity: Cytokine Release Syndrome (CRS) [ Time Frame: Up to 4 weeks ]
  • Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) [ Time Frame: Up to 4 weeks ]
  • Dose Limiting Toxicity [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Central contacts

Catherine Cheng

+1 919-445-4208UNCImmunotherapy@med.unc.edu

Spencer SB Laing

+1 919-445-4175UNCImmunotherapy@med.unc.edu

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Jared Weiss, MD

919-843-7718UNCImmunotherapy@med.unc.edu

Lauren Higgins

UNCImmunotherapy@med.unc.edu

Principal Investigator:

Jared Weiss, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • cellular therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-07-08.