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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 16, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 1, 2026 → Oct 1, 2026
Primary endpoint added 4 → 5 primary endpoints
See other at-risk trials from UNC Lineberger Comprehensive Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Primary completion pushed from Sep 1, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Collaborators: 2 to 3
  2. Phase changed: Phase 1/2 → Phase 1v12
  3. Primary completion date: Aug 2026 to Sep 1, 2026
    • Study completion date: Aug 2028 to Aug 1, 2028
    v11
  4. Start date: Apr 16, 2024 to Apr 5, 2024v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Sep 2026 to Aug 2026
    • Study completion date: Sep 2028 to Aug 2028
    v8
  2. Primary completion date: Aug 2026 to Sep 2026
    • Study completion date: Aug 2028 to Sep 2028
    • Collaborators: 1 to 2
    v7
  3. Start date: Apr 5, 2024 to Apr 16, 2024v6
  4. Re-verified, no change to tracked fieldsv5
  5. Site contact updatedv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Apr 5, 2024
    • Site details revised
    v3
  7. Start date: Dec 2023 to Mar 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06096038
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: Bellicum Pharmaceuticals, National Cancer Institute (NCI), M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Head and Neck Cancer, Relapse, Recurrent, Refractory Cancer
Related terms Head and Neck Neoplasms, Neoplasms, Recurrence
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov