Squamous Cell Carcinoma of Head and NeckPhase 1NCT06236425
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC
A Phase 1 study testing TBio-4101, Pembrolizumab and Platinum based chemotherapy in people with Squamous Cell Carcinoma of Head and Neck and Metastatic Squamous Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Metastatic Squamous Cell Carcinoma
- What is being tested?
- TBio-4101, Pembrolizumab and Platinum based chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 9 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have pathologically confirmed, recurrent, unresectable or metastatic solid tumors of HNSCC, excluding nasopharyngeal and nasal cavity carcinomas, and must have received no prior treatment for metastatic disease.
- Patients must have at least 1 cm3 (1.1 g) of viable tumor tissue amenable for resection for TIL generation, and at least one target tumor that can be used for response assessment by RECIST 1.1 and iRECIST criteria and for mandatory translational tumor biopsy (where applicable).
- Patients must be willing and able to undergo an apheresis procedure.
- Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 3 weeks prior to TIL harvest or apheresis, whichever is earlier, and any prior therapy-related adverse events (AEs) must have resolved to Grade ≤ 1 except for alopecia and vitiligo. Neuropathy and anemia must have resolved to Grade ≤ 2.
- Age 18-75 years at the time of TIL harvest.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Participants given pembrolizumab monotherapy must have a composite positive score ≥ 1.
- Demonstrate adequate organ and marrow function.
- Seronegative for Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C (HCV) antibody (if HCV antibody positive, must be tested for HCV RNA, which must be negative to be eligible).
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- The effects of TBio-4101 on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.
Who cannot join
- Participants with a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Participants who have received prior cell therapy or prior organ transplant.
- Participants who have received any previous treatment with a PD-1 or PD-L1 inhibitor, including but not limited to: nivolumab, atezolizumab, pembrolizumab, avelumab, or durvalumab.
- Participants who are receiving any other investigational agents.
- Participants who have a history of severe immediate hypersensitivity reaction to the study agents or any of their constituents.
- Participants who have a severe allergy to gentamicin (used in the manufacturing of TBio-4101).
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- Participants who have received a live or live-attenuated vaccine within 30 days prior to TIL harvest or apheresis, whichever is earlier. Note: Administration of killed vaccines is allowed.
- Participants who require chronic anti-coagulant therapy that cannot either be discontinued or changed to an anti-coagulant with a relatively short half-life, such as a low molecular weight heparin.
- Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders (such as HIV/AIDS).
- Participants with a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to TIL harvest or apheresis, whichever is earlier.
- Participants with a serious cardiac condition, such as uncontrolled hypertension, concurrent congestive heart failure, prior history of Class III/IV cardiac disease (New York Heart Association [NYHA]), left ventricular ejection fraction (LVEF) <45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment, unless approved by the Sponsor (MCC). Participants who are > 60 years of age must undergo cardiology clearance exam and cardiac stress test, unless performed within the last 6 months and there has been no clinical change with respect to heart function.
- Participants with a forced expiratory volume (FEV1) ≤ 60% of predicted value and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) < 60% of predicted value.
- Participants with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to TIL harvest/ apheresis.
- Participants with active infections requiring parenteral antibiotics that, in the opinion of the Investigator, would increase the risk of adverse events during TIL harvest or apheresis or start of NMA-LD chemotherapy.
- Participants with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
- Pregnant women are excluded from this study because the effects of TBio-4101 on the developing human fetus are unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TBio-4101, breastfeeding should be discontinued.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
- Being tested
- TBio-4101, Pembrolizumab, Platinum based chemotherapy, Cyclophosphamide, Fludarabine
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBio-4101Biological
Also called Tumor-Infiltrating Lymphocyte
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.
PembrolizumabDrug
Also called Keytruda
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.
Platinum based chemotherapyDrug
Also called Cisplatin, Carboplatin/5-FU
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.
CyclophosphamideDrug
Also called Cytoxan
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.
FludarabineDrug
Also called Fludara
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.
AldesleukinDrug
Also called Interleukin-2, IL-2
After completion of TBio-4101 infusion, Aldesleukin will be administered every 8 hours, for up to 6 doses.
| Study group | Role | What they receive |
|---|---|---|
| TIL Harvest/Standard of care Treatment Phase | Other | 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. Receives: Drug: Pembrolizumab; Drug: Platinum based chemotherapy |
| TBio-4101 Treatment | Experimental | 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. Receives: Biological: TBio-4101; Drug: Pembrolizumab; Drug: Platinum based chemotherapy; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
Measured: Up to 2 years
Secondary outcomes (5)
Overall Response Rate (ORR)
ORR will be determined using RECIST 1.1 and RECIST 1.1 for immune-based therapeutics (iRECIST).
Measured: Up to 5 years
Durable Response Rate (DRR)
DRR, will be defined as a continuous CR or partial response (PR) beginning within 12 months of TBio-4101 treatment and lasting ≥ 6 months by RECIST 1.1 and iRECIST.
Measured: Up to 5 years
Duration of Response (DoR)
DoR will be determined using RECIST 1.1 and iRECIST.
Measured: Up to 5 years
Disease Control Rate (DCR)
DCR will be determined using RECIST 1.1 and iRECIST.
Measured: Up to 5 years
Assess the feasibility of TBio-4101
Feasibility of TBio-4101 defined as the percentage of treated-patient population (TPP) patients over intent-to-treat (ITT).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start14 Mar 2024
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Turnstone Biologics, Corp.
- Responsible party
- Sponsor
- Investigators
- Kedar Kirtane, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236425
- Sponsor's protocol ID
- MCC-23098
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06236425
- Acronym / sponsor ID
- MCC-23098
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Turnstone Biologics, Corp.
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIL Harvest/Standard of care Treatment Phase | Other | Drug: Pembrolizumab, Drug: Platinum based chemotherapyParticipants 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. |
| TBio-4101 Treatment | Experimental | Biological: TBio-4101, Drug: Pembrolizumab, Drug: Platinum based chemotherapy, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: AldesleukinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have pathologically confirmed, recurrent, unresectable or metastatic solid tumors of HNSCC, excluding nasopharyngeal and nasal cavity carcinomas, and must have received no prior treatment for metastatic disease.
- Patients must have at least 1 cm3 (1.1 g) of viable tumor tissue amenable for resection for TIL generation, and at least one target tumor that can be used for response assessment by RECIST 1.1 and iRECIST criteria and for mandatory translational tumor biopsy (where applicable).
- Patients must be willing and able to undergo an apheresis procedure.
- Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 3 weeks prior to TIL harvest or apheresis, whichever is earlier, and any prior therapy-related adverse events (AEs) must have resolved to Grade ≤ 1 except for alopecia and vitiligo. Neuropathy and anemia must have resolved to Grade ≤ 2.
- Age 18-75 years at the time of TIL harvest.
Key exclusion criteria (16 listed)
- Participants with a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Participants who have received prior cell therapy or prior organ transplant.
- Participants who have received any previous treatment with a PD-1 or PD-L1 inhibitor, including but not limited to: nivolumab, atezolizumab, pembrolizumab, avelumab, or durvalumab.
- Participants who are receiving any other investigational agents.
- Participants who have a history of severe immediate hypersensitivity reaction to the study agents or any of their constituents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBio-4101Also: Tumor-Infiltrating LymphocyteTBio-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. | Biological | TBio-4101 Treatment |
| PembrolizumabAlso: KeytrudaWill 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 | TBio-4101 Treatment, TIL Harvest/Standard of care Treatment Phase |
| Platinum based chemotherapyAlso: Cisplatin, Carboplatin/5-FUWill 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 | TBio-4101 Treatment, TIL Harvest/Standard of care Treatment Phase |
| CyclophosphamideAlso: CytoxanParticipants 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 | TBio-4101 Treatment |
| FludarabineAlso: FludaraParticipants 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 | TBio-4101 Treatment |
| AldesleukinAlso: Interleukin-2, IL-2After completion of TBio-4101 infusion, Aldesleukin will be administered every 8 hours, for up to 6 doses. | Drug | TBio-4101 Treatment |
Primary outcome
Safety and tolerability
Time frame: Up to 2 years
The incidence of treatment-emergent adverse events will be tabulated using NCI CTCAE v5.0
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 5 years
Durable Response Rate (DRR)
Time frame: Up to 5 years
Duration of Response (DoR)
Time frame: Up to 5 years
Disease Control Rate (DCR)
Time frame: Up to 5 years
Assess the feasibility of TBio-4101
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kedar Kirtane, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBio-4101, Pembrolizumab and Platinum based chemotherapy in people with Squamous Cell Carcinoma of Head and Neck and Metastatic Squamous Cell Carcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.