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

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

Trial Details

NCT ID
NCT06096038
Phase
PHASE1
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Cyclophosphamide
  • Fludarabine
  • Cell Therapy
Locations (sample)
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility Criteria

  • 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; …
  • Age ≥ 18 years at the time of consent.
  • Karnofsky score of \> 60%

For full eligibility, visit ClinicalTrials.gov.

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