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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: Active 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.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0

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
H. Lee Moffitt Cancer Center and Research Institute

502 total trials

What the registry record for NCT06236425 still lists

NCT06236425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (96% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Squamous Cell Carcinoma of Head and Neck

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06236425's enrollment target sits among peer trials

7 37th of 37 higher than 1 of 37 other Squamous Cell Carcinoma of Head and Neck trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06236425, the US trial registry maintained by the National Library of Medicine. NCT06236425 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.