RecruitingPhase 1Phase 2NCT06096038

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

Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

33 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new type of immunotherapy called CAR-T cell therapy in patients with head and neck squamous cell carcinoma (HNSCC) that has come back or spread after prior treatments. The therapy uses the patient's own immune cells, which are genetically engineered in a lab to recognize and attack a protein called CSPG4 found on these cancer cells. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck (including mouth, throat, voice box, or hypopharynx) - You have a Karnofsky performance score above 60% (able to care for yourself with some assistance) - You are willing to provide blood samples for CAR-T cell manufacturing **You may NOT be eligible if...** - You have severe progressive heart disease (e.g., congestive heart failure or recent heart attack) - You have active autoimmune disease or serious uncontrolled infections - You have significant liver or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

cyclophosphamide 300 mg/meter square IV

DRUGFludarabine

fludarabine 30 mg/meter square IV × 3 days

BIOLOGICALCell 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


Locations(1)

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

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NCT06096038


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