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NCT06096038 | RECRUITING | Head and Neck Cancer

Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
Sponsor:

UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease

Head and Neck Cancer

Relapse

Recurrent

Refractory Cancer

Intervention/treatment

Cyclophosphamide

Fludarabine

Cell Therapy

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 33 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)
Actual Study Start Date : 2024-04-16
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2028-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 120 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC

Location Details

NCT06096038

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Locations

RECRUITING

United States, North Carolina

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States, 27599