Engineered CAR-T cells targeting CSPG4 for head and neck cancer
iC9-CAR.CSPG4 CAR-T Cells for Head and Neck Squamous Cell Carcinoma
['FUNDING_R01'] · UNIV OF NORTH CAROLINA CHAPEL HILL · NIH-11235163
This trial gives engineered immune cells (CAR‑T) that target a protein called CSPG4 to adults with head and neck squamous cell carcinoma that has not responded to platinum chemotherapy and PD‑1 therapy.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIV OF NORTH CAROLINA CHAPEL HILL (nih funded) |
| Locations | 1 site (CHAPEL HILL, UNITED STATES) |
| Trial ID | NIH-11235163 on ClinicalTrials.gov |
What this research studies
You would receive a single infusion of specially engineered CAR‑T cells designed to recognize CSPG4 on head and neck cancer cells. This phase I, single‑center, open‑label trial uses a modified 3+3 dose‑escalation followed by a small expansion group to find a safe dose and look for early signs of benefit. Doctors will collect tumor biopsies before and after treatment and take regular blood samples to study how the CAR‑T cells and your own immune cells respond over time. The team will analyze immune markers, T‑cell receptors, exhaustion markers, and metabolic profiles to learn how tumors may resist or be killed by the therapy.
Who could benefit from this research
Good fit: Adults with recurrent or metastatic head and neck squamous cell carcinoma that is refractory to platinum‑based chemotherapy and PD‑1 inhibitors and who meet the trial's medical eligibility criteria.
Not a fit: Patients whose tumors lack CSPG4 expression or who are medically unfit for CAR‑T therapy (for example, due to uncontrolled infections, severe organ dysfunction, or certain autoimmune conditions) may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the therapy could shrink or control tumors in people whose head and neck cancer no longer responds to standard chemotherapy and PD‑1 drugs.
How similar studies have performed: CAR‑T therapies have been highly successful in some blood cancers, but results in solid tumors like head and neck cancer have been limited, so this approach is still relatively experimental for this disease.
Where this research is happening
CHAPEL HILL, UNITED STATES
- UNIV OF NORTH CAROLINA CHAPEL HILL — CHAPEL HILL, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: WEISS, JARED — UNIV OF NORTH CAROLINA CHAPEL HILL
- Study coordinator: WEISS, JARED
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.