Metastatic MelanomaPhase 1NCT05628883
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
A Phase 1 study testing TBio-4101, Cyclophosphamide and Fludarabine in people with Metastatic Melanoma and Unresectable Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes [TIL]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Melanoma, Unresectable Melanoma, Acral Melanoma
- What is being tested?
- TBio-4101, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2022to 6 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically confirmed, unresectable or metastatic melanoma as follows:
- Cutaneous, non-acral, melanoma (including melanoma of unknown primary)
- Cutaneous acral melanoma
- Mucosal melanoma
- Ocular melanoma (including uveal, iris, conjunctival melanoma)
- Participants must have failed, be refractory to, or unable to tolerate standard of care in the opinion of the Investigator. For participants with cutaneous non-acral melanoma, standard of care therapy includes a PD-1/L1 inhibitor, a CTLA-4 inhibitor, and if BRAF V600 activating mutation positive, a BRAF ± MEK inhibitor.
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- Note: if treatment failure occurs during adjuvant therapy or within 6 months of adjuvant therapy completion, this will count as a failure of the applicable regimen as noted above.
- Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting therapy (except for bridging therapy as defined below), and any prior therapy-related AEs must have resolved to Grade ≤ 1 except for alopecia and vitiligo. Neuropathy must have resolved to Grade ≤ 2.
- Participants must be between the ages of 18 and 75 years old. Additionally, participants who are ≥ 60 years of age must undergo a cardiology evaluation including a cardiac stress test after which they must be deemed to be low/acceptable risk.
- ECOG performance status of 0 or 1
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mcL (non-growth factor supported)
- Platelet count ≥ 100,000/mcL
- Hemoglobin ≥ 8.0 g/dL
- AST (SGOT)/ALT (SGPT) ≤ 3 times the institutional ULN; ≤ 5 times ULN if patient has liver metastasis
- Cockcroft-Gault estimated GFR ≥ 50 mL/min (creatinine)
- Total bilirubin ≤ 2.0 mg/dL (except in patients with Gilbert's Syndrome where the bilirubin must be ≤ 3 mg/dL)
- 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)
- Participants with brain metastases are eligible provided that the brain metastases have been successfully treated with stereotactic radiosurgery or resection and clinically stable for at least 1 month.
- Participants who have not undergone prior TIL harvest (i.e., the patient was not enrolled in the Banked TIL protocol MCC# <TBD>) must have at least 1 cm of tumor amenable for resection for TIL generation, in addition to, having at least one target lesion that can be used for response assessment by RECIST 1.1 criteria after TIL harvest.
- Participants who have undergone prior TIL harvest with the banking protocol (MCC# <TBD>) must have adequate numbers of cryopreserved TIL after the pre-REP to meet criteria for proceeding with TBio-4101 therapy.
- Participants must be willing and able to undergo an apheresis procedure
- Women of child-bearing potential must have a negative pregnancy test
- The effects of TBio-4101 on the developing human fetus are unknown. For this reason and because TIL agents, as well as other therapeutic agents used in this trial including IL-2 are known to be teratogenic, both males and females of child-bearing potential must be willing to practice birth control starting with screening through 1 year after the last study drug is administered for females or 6 months for males. Note: Women of child-bearing potential must have a negative serum pregnancy test.
- Contraception requirement:
- To prevent pregnancy, patients who are able to conceive or father children must use a highly effective contraception method during sexual activity starting with Screening through 1 year after the last study drug is administered for females or 6 months for males.
- Based on their mechanisms of action, the NMA-LD chemotherapy, aldesleukin (IL-2), can cause fetal harm when administered to a pregnant woman. Effects of TBio-4101 on fetal development are unknown.
- Definition of Non-Reproductive Potential: For this trial, male patients will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition). Female patients will be considered of non-reproductive potential if they are either: (a) postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single follicle FSHH measurement is insufficient); (b) Or have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening; (c) Or has a congenital or acquired condition that prevents childbearing.
- Definition of Highly Effective Contraception: The following are examples of acceptable contraception methods to prevent pregnancy. This list may not be comprehensive for all regions, so the Investigator must discuss sexual activity and contraception usage with the patient. Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection, Intrauterine device (IUD), Intrauterine hormone releasing system (IUS), Bilateral tubal occlusion, Vasectomized partner.
- Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants, regardless of age, who have a current or past medical history of ischemic heart disease, or clinically significant atrial or ventricular rhythm abnormality are excluded unless they undergo a cardiac stress test and cardiology clearance examination and are determined to be low or acceptable risk.
- Note: Participants with any clinically significant cardiac wall movement abnormality are excluded.
- Participants who have received prior cell therapy.
- Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders (such as HIV/AIDS)
- Pregnant women are excluded from this study because the agents used in this study have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TBio-4101 or the other agents in the study, breastfeeding should be discontinued if the mother is enrolled in the study.
- Participants taking systemic steroid therapy (other than replacement therapy) or therapy with any immunosuppressive medications such as mycophenolate mofetil (MMF). Participants who require dapsone for pneumocystis pneumonia (PCP) prophylaxis during TIL therapy are eligible.
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- Participants who have a history of severe immediate hypersensitivity reaction to the study agents including cyclophosphamide, fludarabine, or aldesleukin/ IL-2 or any of their constituents
- Participants with a left ventricular ejection fraction (LVEF) ≤ 45% or New York Heart Association (NYHA) functional classification > 1
- Forced expiratory volume (FEV1) ≤ 60% of predicted value and DLCO (corrected) < 60% of predicted value
- Participants who, in the opinion of the Investigator, have a medical condition that would subject the patient to prohibitive risk by participation in this study, or who may be unable to safely complete the apheresis, tumor harvest, lymphodepletion regimen, TIL infusion, or aldesleukin/ IL-2 administration
- Participants with active infections requiring parenteral antibiotics
- Participants with autoimmune disease currently or within the past 6 months requiring systemic treatment with immunosuppressive doses of corticosteroids (>10 mg of prednisone-equivalent daily dosing), immunosuppressive biologic agents, or disease modifying antirheumatic drug agents (DMARDs).
- Note: Participants with autoimmune thyroiditis on replacement thyroid medication are eligible.
- Participants requiring chronic anti-coagulant therapy that cannot either be discontinued or changed to an anti-coagulant such as a low molecular weight heparin, which has a relatively short half-life, if clinically indicated during the period of thrombocytopenia resulting from the lymphodepletion regimen
- Has evidence of impeding perforation, obstruction or bleeding (requiring transfusion) due to the tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Study of TBio-4101 (an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte [TIL] Therapy) Using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients With Relapsed or Refractory Melanoma (Phase 1)
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes [TIL]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.
- Conditions
- Metastatic Melanoma, Unresectable Melanoma, Acral Melanoma, Mucosal Melanoma, Cutaneous Melanoma, Ocular Melanoma
- Being tested
- TBio-4101, Cyclophosphamide, Fludarabine, Interleukin-2
- Keywords
- Melanoma
- Medical subject headings
- Melanoma, Uveal Melanoma
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.
CyclophosphamideDrug
Also called Cytoxan, Neosar
Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days.
FludarabineDrug
Also called Fludara
Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion
Interleukin-2Drug
Also called IL-2
Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Infusion of TBio-4101 TIL | Experimental | TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product: participants tumor tissue is surgically removed and immune T-cells are taken out of the tumor and multiplied, or grown, in the laboratory. TIL product infused intravenously over 20 to 30 minutes within 2 to 4 days after the last dose of fludarabine
Participants will also receive:
* Cyclophosphamide dose 60 mg/kg/day for 2 days administered IV in 250 mL dextrose 5% in water infused simultaneously with Mesna 15 mg/kg/day delivered over 1 hour per day for 2 days. Fludarabine 25 mg/m2/day is delivered by intravenous piggyback daily over 15-30 minutes for 5 days.
* Interleukin-2 (IL-2)- will be given to participants through IV after they receive the infusion of the TIL. IL-2 is administered at a dose of 600,000 IU/kg (based on actual body weight) IV every 8-12 hours beginning within 24 hours of TIL infusion for a maximum of 6 doses. Receives: Biological: TBio-4101; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants that Successfully Receive TBio-4101
Percentage of participants who undergo tumor resection that successfully receive TBio-4101
Measured: Day 7
Secondary outcomes (6)
Objective Response Rate (OOR)
ORR will be calculated using irRECIST and RECIST v1.1
Measured: 2 years after receiving TIL Transfer
6 Month Overall Survival (OS)
OS is defined as the time from enrollment to death
Measured: at 6 Months
12 Month Overall Survival (OS)
OS is defined as the time from enrollment to death
Measured: at 12 Months
6 Month Progression Free Survival (PFS)
PFS is defined as the time from study enrollment until disease progression or death.
Measured: at 6 Months
12 Month Progression Free Survival (PFS)
PFS is defined as the time from study enrollment until disease progression or death.
Measured: at 12 Months
Durable Response Rate (DRR)
DRR is defined as a continuous response, beginning within 12 months of treatment and lasting > 6 months
Measured: Up to 6 Months after 12 months of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start22 Nov 2022
- Primary completion3 Dec 2024
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Turnstone Biologics, Corp.
- Responsible party
- Sponsor
- Investigators
- Amod Sarnaik, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628883
- Sponsor's protocol ID
- MCC-21707
- Status last verified
- Mar 2026
- First submitted
- 14 Nov 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study of TBio-4101 (an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte [TIL] Therapy) Using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients With Relapsed or Refractory Melanoma (Phase 1)
- ClinicalTrials.gov ID
- NCT05628883
- Acronym / sponsor ID
- MCC-21707
- Conditions
- Metastatic Melanoma, Unresectable Melanoma, Acral Melanoma, Mucosal Melanoma, Cutaneous Melanoma, Ocular Melanoma
- Keywords
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Turnstone Biologics, Corp.
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 29 Nov 2022 (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.
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes [TIL]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion of TBio-4101 TIL | Experimental | Biological: TBio-4101, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product: participants tumor tissue is surgically removed and immune T-cells are taken out of the tumor and multiplied, or grown, in the laboratory. TIL product infused intravenously over 20 to 30 minutes within 2 to 4 days after the last dose of fludarabine Participants will also receive: * Cyclophosphamide dose 60 mg/kg/day for 2 days administered IV in 250 mL dextrose 5% in water infused simultaneously with Mesna 15 mg/kg/day delivered over 1 hour per day for 2 days. Fludarabine 25 mg/m2/day is delivered by intravenous piggyback daily over 15-30 minutes for 5 days. * Interleukin-2 (IL-2)- will be given to participants through IV after they receive the infusion of the TIL. IL-2 is administered at a dose of 600,000 IU/kg (based on actual body weight) IV every 8-12 hours beginning within 24 hours of TIL infusion for a maximum of 6 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Participants must have histologically confirmed, unresectable or metastatic melanoma as follows:
- Participants must have failed, be refractory to, or unable to tolerate standard of care in the opinion of the Investigator. For participants with cutaneous non-acral melanoma, standard of care therapy includes a PD-1/L1 inhibitor, a CTLA-4 inhibitor, and if BRAF V600 activating mutation positive, a BRAF ± MEK inhibitor.
- Note: if treatment failure occurs during adjuvant therapy or within 6 months of adjuvant therapy completion, this will count as a failure of the applicable regimen as noted above.
- Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting therapy (except for bridging therapy as defined below), and any prior therapy-related AEs must have resolved to Grade ≤ 1 except for alopecia and vitiligo. Neuropathy must have resolved to Grade ≤ 2.
- Participants must be between the ages of 18 and 75 years old. Additionally, participants who are ≥ 60 years of age must undergo a cardiology evaluation including a cardiac stress test after which they must be deemed to be low/acceptable risk.
Key exclusion criteria (15 listed)
- Participants, regardless of age, who have a current or past medical history of ischemic heart disease, or clinically significant atrial or ventricular rhythm abnormality are excluded unless they undergo a cardiac stress test and cardiology clearance examination and are determined to be low or acceptable risk.
- Note: Participants with any clinically significant cardiac wall movement abnormality are excluded.
- Participants who have received prior cell therapy.
- Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders (such as HIV/AIDS)
- Pregnant women are excluded from this study because the agents used in this study have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TBio-4101 or the other agents in the study, breastfeeding should be discontinued if the mother is enrolled in the study.
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 | Infusion of TBio-4101 TIL |
| CyclophosphamideAlso: Cytoxan, NeosarParticipants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days. | Drug | Infusion of TBio-4101 TIL |
| FludarabineAlso: FludaraParticipants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion | Drug | Infusion of TBio-4101 TIL |
| Interleukin-2Also: IL-2Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion. | Drug | Infusion of TBio-4101 TIL |
Primary outcome
Percentage of Participants that Successfully Receive TBio-4101
Time frame: Day 7
Percentage of participants who undergo tumor resection that successfully receive TBio-4101
6 secondary outcomes
Objective Response Rate (OOR)
Time frame: 2 years after receiving TIL Transfer
6 Month Overall Survival (OS)
Time frame: at 6 Months
12 Month Overall Survival (OS)
Time frame: at 12 Months
6 Month Progression Free Survival (PFS)
Time frame: at 6 Months
12 Month Progression Free Survival (PFS)
Time frame: at 12 Months
Durable Response Rate (DRR)
Time frame: Up to 6 Months after 12 months of Treatment
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 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Amod Sarnaik, 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, Cyclophosphamide and Fludarabine in people with Metastatic Melanoma and Unresectable Melanoma, 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 31 inclusion and 15 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 2 Apr 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?
Percentage of Participants that Successfully Receive TBio-4101 (time frame: Day 7). 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 2 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.