Actively Recruiting
Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-02-20
33
Participants Needed
1
Research Sites
100 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
Researchers are studying a new treatment called autologous T lymphocyte chimeric antigen receptor cells targeting the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that has returned after standard therapy. This experimental treatment has not been approved by the Food and Drug Administration. The study aims to find the safe dose levels and maximum tolerated dose of these modified T cells to help inform future treatments for cancer patients. The study has two parts: first, blood is collected from participants to isolate and modify disease-fighting T cells to create the iC9.CAR-CSPG4 T cells. In the second part, participants receive lymphodepletion chemotherapy followed by an infusion of the modified T cells. Dose escalation is used to determine the recommended phase 2 dose based on safety and tolerability. Participants will be monitored for side effects including toxicity, cytokine release syndrome, and neurotoxicity up to four weeks after treatment. The study will also track the objective response rate for up to two years. Follow-up continues after treatment completion or discontinuation, including safety monitoring related to the gene transfer procedure. The total participation duration varies based on treatment and follow-up.
CONDITIONS
Brief 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%
- Confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx)
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 past 6 months)
- History of stroke or transient ischemic attack within 12 months before enrollment
- History of severe immediate allergic reaction to cyclophosphamide or fludarabine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive lymphodepletion chemotherapy followed by infusion of autologous CAR-T cells targeting CSPG4.
Multiple visits during chemotherapy and CAR-T cell infusion period
Duration - Up to 2 years
Participants are monitored for toxicity and response after treatment.
Regular follow-up visits for up to 2 years
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
S
Spencer SB Laing
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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