Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
NCT ID: NCT06096038
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2024-04-05
2028-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chimeric Antigen Receptors
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.
Cyclophosphamide
cyclophosphamide 300 mg/meter square IV
Fludarabine
fludarabine 30 mg/meter square IV × 3 days
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
Interventions
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Cyclophosphamide
cyclophosphamide 300 mg/meter square IV
Fludarabine
fludarabine 30 mg/meter square IV × 3 days
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Bellicum Pharmaceuticals
INDUSTRY
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jared Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Jared Weiss, MD
Role: primary
Lauren Higgins
Role: backup
Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2060-ATL
Identifier Type: -
Identifier Source: org_study_id