Status:
RECRUITING
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
Bellicum Pharmaceuticals
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Relapse
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 cell...
Eligibility Criteria
Inclusion
- Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:
- 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.
- Age ≥ 18 years at the time of consent.
- Karnofsky score of \> 60%
- 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
- 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.
- Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.
- Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.
Key Trial Info
Start Date :
April 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06096038
Start Date
April 5 2024
End Date
August 1 2028
Last Update
November 26 2025
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599