Actively Recruiting
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-02-20
33
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
B
Bellicum Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization
- Age 18 years or older at consent
- Karnofsky score greater than 60%
- Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck, including oral cavity, oropharynx, hypopharynx, and larynx cancer
You will not qualify if you...
- History or current severe progressive heart disease including congestive heart failure, coronary artery disease, uncontrolled hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months
- History of stroke or transient ischemic attack within 12 months before study
- History of severe immediate allergic reaction to cyclophosphamide or fludarabine
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Catherine Cheng
CONTACT
S
Spencer SB Laing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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