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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: Recruiting Phase 1 study of Head and Neck Cancer and Refractory Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2028-08-01 |
| Phase | Phase 1 |
What NCT06096038 shows while recruiting
NCT06096038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06096038's enrollment target sits among peer trials
33 169th of 250 higher than 79 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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