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

NCT06236425 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-01

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of Head and Neck
  • Metastatic Squamous Cell Carcinoma

Interventions

BIOLOGICAL

TBio-4101

TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell.

DRUG

Pembrolizumab

Will be administered as per standard of care. Participants with initial partial or complete radiographic response will continue on the same therapy at the discretion of the treating physician.

DRUG

Platinum based chemotherapy

Will be administered as per standard of care. Participants with initial partial or complete radiographic response will continue on the same therapy at the discretion of the treating physician.

DRUG

Cyclophosphamide

Participants who proceed to TBio-4101 treatment will receive Cyclophosphamide as part of a non-myeloablative lymphodepletion (NMA-LD) chemotherapy regimen prior to TBio-4101 infusion.

DRUG

Fludarabine

Participants who proceed to TBio-4101 treatment will receive Fludarabine as part of a non-myeloablative lymphodepletion (NMA-LD) chemotherapy regimen prior to TBio-4101 infusion.

DRUG

Aldesleukin

After completion of TBio-4101 infusion, Aldesleukin will be administered every 8 hours, for up to 6 doses.

Sponsors & Collaborators

  • Turnstone Biologics, Corp.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Kedar Kirtane, MD · Moffitt Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2025-04-09
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236425 on ClinicalTrials.gov