Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclophosphamide, Fludarabine, Cell Therapy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Relapse, Recurrent, Refractory Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)
Overview
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.
Interventions
- Drug Cyclophosphamide
cyclophosphamide 300 mg/meter square IV - Drug Fludarabine
fludarabine 30 mg/meter square IV × 3 days - Biological Cell Therapy
the autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen iC9-CAR.CSPG4 T cell infusion iC9-CAR.CSPG4 T cell infusion
Primary outcome measures
- Toxicity: NCI-CTCAE [Time frame: Up to 4 weeks]
- Toxicity: Cytokine Release Syndrome (CRS) [Time frame: Up to 4 weeks]
- Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) [Time frame: Up to 4 weeks]
- Dose Limiting Toxicity [Time frame: Up to 4 weeks]
Secondary outcome measures (2)
- The recommended phase 2 dose (RP2D) of iC9-CAR.CSPG4 [Time frame: Up to 4 weeks]
- Objective response rate [Time frame: Up to 2 years]
Eligibility criteria
Inclusion 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; 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06096038 · LCCC2060-ATL · R01CA296807-01