TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC (NCT06236425)
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)
🩺 Plain-English Summary (8th-Grade Level)
Phase 1b open-label study to evaluate the safety of selected TIL (TBio-4101) delivered after lymphodepleting chemotherapy and followed by intravenous (IV) bolus aldesleukin (IL-2) and pembrolizumab for patients with advanced HNSCC who have initially progressed on pembrolizumab or pembrolizumab/platinum chemotherapy.
Who can join: Review the eligibility criteria below.
Location: Moffitt Cancer Center — Tampa, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Moffitt Cancer Center — Tampa, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Squamous Cell Carcinoma of Head and Neck
- Pembrolizumab Plus Olaparib in LA-HNSCC — Indianapolis, Indiana
- HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer — Dallas, Texas
- MicroRNA Markers in Head and Neck Cancers — Aurora, Colorado
- A Clinical Trial Evaluating TG4050 in Head and Neck Cancer — Jacksonville, Florida
- A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer — La Jolla, California
Explore by condition: All Squamous Cell Carcinoma of Head and Neck clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.