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Checkpoint Inhibitor

TIL Harvest/Standard of care Treatment Phase for Squamous Cell Carcinoma

Phase 1

Recruiting

Led By Kedar Kirtane, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be willing and able to undergo an apheresis procedure.

Participants given pembrolizumab monotherapy must have a composite positive score ≥ 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new treatment for advanced head and neck cancer. It involves giving patients a combination of chemotherapy, a drug called TIL (TBio-4101), and two other drugs called

Who is the study for?

This trial is for adults with advanced head and neck squamous cell carcinoma (HNSCC) who have seen their cancer progress despite treatment with pembrolizumab or a combination of pembrolizumab and platinum-based chemotherapy.Check my eligibility

What is being tested?

The study tests TBio-4101, a type of tumor-infiltrating lymphocyte therapy, after chemo that reduces immune cells. It's followed by aldesleukin to boost the immune system and more pembrolizumab to help fight the cancer.See study design

What are the potential side effects?

Possible side effects include reactions from the infusion, low blood counts, fatigue, nausea, fever due to aldesleukin; plus typical issues from immunotherapies like skin rash or inflammation in organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to undergo a procedure to collect my blood cells.

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I have a score of 1 or more for pembrolizumab treatment eligibility.

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I do not have HIV, hepatitis B, or active hepatitis C.

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My cancer is a specific type that has returned or spread and hasn't been treated yet.

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I have a tumor large enough for tissue removal and assessment.

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I finished any cancer treatments 3 weeks ago, and side effects are mild except for hair loss or skin color changes.

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I am between 18 and 75 years old.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability

Secondary outcome measures

Assess the feasibility of TBio-4101

Disease Control Rate (DCR)

Durable Response Rate (DRR)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: TIL Harvest/Standard of care Treatment PhaseExperimental Treatment2 Interventions

Participants will undergo tumor harvest for TIL and then receive 2 to 3 cycles of pembrolizumab or pembrolizumab/platinum chemotherapy (cisplatin or carboplatin / 5-FU) as per standard of care.

Group II: TBio-4101 TreatmentExperimental Treatment6 Interventions

Participants without radiographic response (progressive disease) after pembrolizumab or pembrolizumab/platinum chemotherapy, and who meet eligibility requirements, will transition to receive TBio-4101. Participants will receive TBio-4101 infusion and after completion of TBio-4101 infusion, IL-2 will be administered every 8 hours, for up to 6 doses. Finally, pembrolizumab will be administered on Day 14, Day 35, and Day 56 and Q6W (beginning Week 12) thereafter for up to 2 years until discontinuation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

2012

Completed Phase 4

~1620

Pembrolizumab

2017

Completed Phase 2

~2010

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,467 Total Patients Enrolled

Turnstone Biologics, Corp.Industry Sponsor

6 Previous Clinical Trials

136 Total Patients Enrolled

Kedar Kirtane, MDPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this ongoing trial?

"According to the information provided on clinicaltrials.gov, this particular trial is currently not actively seeking participants. The initial posting of the trial was on February 1st, 2024, and it was last edited on January 24th, 2024. However, it's worth noting that there are currently a total of 2694 other trials actively enrolling patients at this time."

Answered by AI

Has the FDA granted approval for the use of TIL Harvest/Standard of care Treatment Phase as a recognized medical procedure?

"This trial is classified as a Phase 1 study, indicating limited data supporting the safety and efficacy of TIL Harvest/Standard of care Treatment Phase. Therefore, our team at Power rates its safety level as 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236425.

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