Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony nowotwór złośliwy głowy i szyi (jama ustna, gardło, głośnia), który powrócił lub rozprzestrzenił się na inne części ciała
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (wynik Karnofskiego powyżej 60%)
- •Podpisana świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Poważne choroby serca w przeszłości lub obecnie (np. zawał w ostatnich 6 miesiącach, arytmia bez kontroli)
- •Udar mózgu lub przejściowy atak niedokrwienny w ostatnich 12 miesiącach
- •Ciężka alergiczna reakcja na leki chemioterapeutyczne cyklofosfamid lub fludarabinę w przeszłości
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 8, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, United States
Trial contact
Catherine Cheng
Spencer SB Laing
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.
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