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Trial Title:
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
NCT ID:
NCT06096038
Condition:
Head and Neck Cancer
Relapse
Recurrent
Refractory Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Conditions: Keywords:
cellular therapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
cyclophosphamide 300 mg/meter square IV
Arm group label:
Chimeric Antigen Receptors
Other name:
Cycloblastin
Other name:
Cytoxan
Other name:
Endoxan
Other name:
Neosar
Other name:
Procytox
Other name:
Revimmune
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
fludarabine 30 mg/meter square IV × 3 days
Arm group label:
Chimeric Antigen Receptors
Other name:
Fludara
Other name:
Fludarabine Phosphate
Intervention type:
Biological
Intervention name:
Cell Therapy
Description:
the autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen
iC9-CAR.CSPG4 T cell infusion iC9-CAR.CSPG4 T cell infusion
Arm group label:
Chimeric Antigen Receptors
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Unless otherwise noted, subjects must meet all of the following criteria to participate
in all phases of the study:
1. 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.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of > 60%
4. 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 Criteria:
1. 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.
2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months
before procurement.
3. Subject with a history of severe immediate hypersensitivity reaction to
cyclophosphamide or fludarabine.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jared Weiss, MD
Phone:
919-843-7718
Email:
UNCImmunotherapy@med.unc.edu
Contact backup:
Last name:
Lauren Higgins
Email:
UNCImmunotherapy@med.unc.edu
Investigator:
Last name:
Jared Weiss, MD
Email:
Principal Investigator
Start date:
April 5, 2024
Completion date:
August 2028
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Bellicum Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
University Cancer Research Fund at Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06096038
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
