Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
Status:
Recruiting
Trial end date:
2028-08-01
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborators:
Bellicum Pharmaceuticals University Cancer Research Fund at Lineberger Comprehensive Cancer Center