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NCT06096038 · ClinicalTrials.gov registry record · Phase 1

Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC

A Phase 1 study of Head and Neck Cancer and Refractory Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
33
Enrollment target
1
Study location

NCT06096038 is a Phase 1 study of Head and Neck Cancer and Refractory Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 33 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06096038, a Phase 1 study of Head and Neck Cancer and Refractory Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
33 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Head and Neck Cancer Refractory Cancer Relapse Recurrent

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL Cell Therapy

Study Locations (1)

North Carolina

  • Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill - Chapel Hill

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2024-04-05
Est. Completion 2028-08-01
Phase Phase 1

Sponsor

UNC Lineberger Comprehensive Cancer Center

366 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06096038

The ClinicalTrials.gov registry entry for NCT06096038 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower). The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.

NCT06096038 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT06096038 about?

NCT06096038 is a clinical study titled "Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC". 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 ca...

What is the current status of trial NCT06096038?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2024-04-05. Estimated completion is 2028-08-01.

What conditions does trial NCT06096038 study?

This clinical trial studies the following conditions: Head and Neck Cancer, Refractory Cancer, Relapse, Recurrent.

What interventions are being tested in trial NCT06096038?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Cell Therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT06096038?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06096038 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.