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Cytokine

TBio-4101 + Chemo + IL-2 for Skin Cancer

Phase 1
Recruiting
Led By Amod Sarnaik, 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
Participants must be willing and able to undergo an apheresis procedure
Participants must have ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Study Summary

This trial tests a new drug to treat metastatic melanoma, to see if it is safe, effective and feasible.

Who is the study for?
This trial is for adults aged 18-75 with unresectable or metastatic melanoma, including various types like cutaneous and ocular melanoma. Participants must have adequate organ function, an ECOG status of 0 or 1, and be willing to practice birth control. Those with treated brain metastases, a negative pregnancy test (if applicable), and the ability to sign consent can join. Excluded are pregnant women, those with severe heart issues or immunodeficiency disorders, active infections requiring IV antibiotics, history of severe allergies to study drugs, certain lung function impairments, autoimmune diseases needing steroids in the past 6 months.Check my eligibility
What is being tested?
The trial tests TBio-4101 therapy using tumor infiltrating lymphocytes after lymphodepleting chemotherapy followed by interleukin-2 (IL-2) in participants with advanced melanoma. It aims to assess if this approach is feasible and safe while also evaluating its effectiveness against the cancer.See study design
What are the potential side effects?
Potential side effects may include reactions from immune system activation such as fever and fatigue; effects from chemotherapy like nausea and low blood cell counts; risks associated with IL-2 treatment which could involve fluid retention and low blood pressure; plus site-specific reactions from TIL infusion.

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 can carry out all my usual activities without help.
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I am between 18 and 75 years old.
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My organs and bone marrow are working well.
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I am a woman who can have children and my pregnancy test is negative.
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I have a tumor larger than 1 cm that can be surgically removed for TIL therapy.
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I have enough stored TIL cells for TBio-4101 therapy after a pre-REP.
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My melanoma cannot be removed by surgery and includes skin, mucosal, or eye melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants that Successfully Receive TBio-4101
Secondary outcome measures
12 Month Overall Survival (OS)
12 Month Progression Free Survival (PFS)
6 Month Overall Survival (OS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Infusion of TBio-4101 TILExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Interleukin-2
1994
Completed Phase 3
~700
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Turnstone Biologics, Corp.Industry Sponsor
6 Previous Clinical Trials
126 Total Patients Enrolled
3 Trials studying Melanoma
87 Patients Enrolled for Melanoma
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,470 Total Patients Enrolled
43 Trials studying Melanoma
3,193 Patients Enrolled for Melanoma
Amod Sarnaik, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Interleukin-2 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT05628883 — Phase 1
Melanoma Research Study Groups: Infusion of TBio-4101 TIL
Melanoma Clinical Trial 2023: Interleukin-2 Highlights & Side Effects. Trial Name: NCT05628883 — Phase 1
Interleukin-2 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05628883 — Phase 1

Frequently Asked Questions

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

Could I be included in this research endeavor?

"This clinical trial is recruiting 25 individuals aged between 18 and 75 with cutaneous melanoma. The inclusion criteria are as follows: a cardiac stress test for participants over 60 to assess the risk of their condition, an absolute neutrophil count ≥ 1,500/mcL (non-growth factor supported), prior systemic therapies must have been completed 4 weeks before lymphodepleting therapy unless they were considered "bridging", any side effects from prior treatments need to be at Grade ≤1 except alopecia or vitiligo which can be up to Grade 2., good performance status (ECOG 0 or 1), refractory"

Answered by AI

To what extent does TBio-4101 TIL infusion pose a risk to human health?

"Our team's estimation of Infusion of TBio-4101 TIL safety rated at 1 because this clinical trial is in the first phase. Consequently, there are limited data points to validate its efficacy and security."

Answered by AI

Are there still vacancies in this research project for participants?

"Confirmed. According to the information present on clinicaltrials.gov, this investigation is currently looking for individuals to participate in their experiment which was initially posted November 8th 2022 and most recently updated on 18th of that month. 25 subjects are being recruited from a single location."

Answered by AI

What is the scope of recruitment for this experiment?

"Affirmative. Clinicaltrials.gov has updated information that this trial is actively recruiting subjects and was published on the 8th of November 2022, with a recent edit on 18th November 2022. 25 patients are required from 1 research center for enrolment into this study."

Answered by AI

Are individuals aged 55 or older being considered for enrollment in this trial?

"This medical trial is open to those aged 18 or above and 75 or below, as indicated by the enrolment criteria."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
2022. "Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05628883.
~5 spots leftby Aug 2024
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