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NCT06236425 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Metastatic Squamous Cell Carcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Active
Registry status
Phase 1
Development phase
7
Enrollment target
1
Study location

NCT06236425 is a Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Metastatic Squamous Cell Carcinoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 7 participants, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06236425, a Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Metastatic Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
7 participants
Enrollment target
1
Study location

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 Studied

Squamous Cell Carcinoma of Head and Neck Metastatic Squamous Cell Carcinoma

Interventions

  • DRUG Pembrolizumab
  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Platinum based chemotherapy
  • BIOLOGICAL TBio-4101

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2024-03-14
Est. Completion 2026-08
Phase Phase 1

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

502 total trials

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What the Registry Record Tells You About NCT06236425

The ClinicalTrials.gov registry entry for NCT06236425 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (96% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT06236425 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT06236425 about?

NCT06236425 is a clinical study titled "TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC". 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/plati...

What is the current status of trial NCT06236425?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2024-03-14. Estimated completion is 2026-08.

What conditions does trial NCT06236425 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck, Metastatic Squamous Cell Carcinoma.

What interventions are being tested in trial NCT06236425?

The interventions under investigation include: Pembrolizumab (DRUG), Cyclophosphamide (DRUG), Fludarabine (DRUG), Platinum based chemotherapy (DRUG), TBio-4101 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06236425?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06236425 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.