deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 2-arm NCT06236425

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC

A Phase IB Clinical Study of TBio-4101 (Autologous Selected and Expanded Tumor-Infiltrating Lymphocytes [TIL]) and Pembrolizumab With or Without Chemotherapy in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Updated 9 times since 2024 Last updated: Jan 6, 2026 Started: Mar 14, 2024 Primary completion: Apr 9, 2025 Completion: Aug 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Metastatic Squamous Cell Carcinoma and Squamous Cell Carcinoma of Head and Neck, this trial is ongoing. The trial is conducted by H. Lee Moffitt Cancer Center and Research Institute and has accumulated 9 data snapshots since 2024. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshotRecruiting~Dec 2024 – ~Mar 2025 · 3 months · monthly snapshotRecruiting~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~Jul 2025 · 3 months · monthly snapshotRecruiting~Jul 2025 – ~Feb 2026 · 7 months · monthly snapshotActive Not Recruiting~Feb 2026 – present · 6 months · monthly snapshotActive Not Recruiting

Change History

9 versions recorded
  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Jul 2025 — Feb 2026 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  3. Apr 2025 — Jul 2025 [monthly]

    Recruiting PHASE1

  4. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE1

  5. Dec 2024 — Mar 2025 [monthly]

    Recruiting PHASE1

Show 4 earlier versions
  1. Sep 2024 — Dec 2024 [monthly]

    Recruiting PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  3. Apr 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  4. Mar 2024 — Apr 2024 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • H. Lee Moffitt Cancer Center and Research Institute
  • Turnstone Biologics, Corp.
Data source: H. Lee Moffitt Cancer Center and Research Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations