CAR-T Cell Therapy for Relapsed/Refractory Head and Neck Cancer
This study is testing a new treatment called iC9-CAR.CSPG4 T cell infusion for people with head and neck cancer that has come back or hasn't responded to standard treatments. This treatment uses your own immune cells, called T cells, which are specially trained to target cancer cells. Researchers want to find out how safe this treatment is, how many side effects it causes, and what dose is best. The study plans to enroll 33 participants aged 18 or older. This treatment is experimental and has not been approved by the FDA. The main goal is to check for side effects like general toxicity, cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS) within the first four weeks.
- Study design
- This is an interventional study with a planned enrollment of 33 participants. It is not specified if it is randomized or blinded.
- What's involved
- In Part 1 of the study, blood will be collected from you to prepare the iC9-CAR-CSPG4 T cells.
- Compensation
- Not stated in the trial record.
- Follow-up
- Toxicity will be measured for up to 4 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jared Weiss, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
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What this trial measures
- Toxicity: NCI-CTCAEUp to 4 weeks
Toxicity will be graded as the Number of participants with adverse events (AE)s AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Dose Limiting Toxicities (DLTs) is defined as at least possibly related to CAR.B7-H3T cell product administration.
- Toxicity: Cytokine Release Syndrome (CRS)Up to 4 weeks
CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild: Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate: Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe: Fever ≥ 38\^ o C, Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening: Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death
- Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)Up to 4 weeks
Neurotoxicity will be graded according to the Immune effector cell-associated neurotoxicity syndrome (ICANS) criteria. Immune effector cell-associated neurotoxicity syndrome (ICANS) symptoms will be graded according to the criteria outlined in the protocol on a scale from 1 (mild) to 4 (critical). Cytokine release syndrome (CRS) will be graded according to criteria outlined in the protocol on a scale from 1 (mild) to grade 5 (death).
- Dose Limiting ToxicityUp to 4 weeks
An event will be considered a Dose limiting toxicity per NCI CTCAE version 5.0, the CRS Grading and ICANS grading criteria. * Grade 3-5 allergic reactions related to the CAR-T cell infusion. * A treatment-emergent Grade 3 CRS that does not improve to Grade 0-1 by 72 hours or Grade 4 CRS * Grade ≥3 ICANS that is unresponsive to the standard of care interventions and does not decrease to Grade ≤1 within 7 days or grade 4 ICANS of any duration that has evidence of cerebral edema and/or generalized convulsive status epilepticus. * Any treatment-emergent Grade 4 non-hematologic AE that does not resolve to Grade 2 within 7 days. * Any Grade 5 events are not due to the underlying malignancy.