TBio-4101 + Chemo + IL-2 for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new treatment that uses a patient's own immune cells, grown in a lab, to fight advanced melanoma that cannot be removed by surgery or has spread. The goal is to see if this approach is safe and effective. Using a patient's own immune cells to fight cancer has shown promise in treating advanced melanoma.
Will I have to stop taking my current medications?
The trial requires that any systemic therapy, including anti-cancer monoclonal antibodies, must be stopped at least 4 weeks before starting the lymphodepleting therapy. Additionally, participants taking systemic steroid therapy or immunosuppressive medications are excluded from the trial.
What safety information is available for the combination of TBio-4101, chemotherapy, and IL-2 in treating skin cancer?
Interleukin-2 (IL-2) has been studied extensively and is known to cause reversible but often severe side effects, such as low blood pressure, swelling, and kidney issues, especially at higher doses. These side effects require careful monitoring and supportive care in a critical-care setting. Other common side effects include fever, fatigue, nausea, and muscle pain, but these are generally manageable and reversible.12345
How is the TBio-4101 + Chemo + IL-2 treatment for skin cancer different from other treatments?
This treatment is unique because it combines TBio-4101, a form of interleukin-2 (a protein that boosts the immune system), with chemotherapy and tumor-infiltrating lymphocytes (TILs), which are immune cells that target cancer cells. This combination aims to enhance the body's immune response against skin cancer, potentially offering greater effectiveness than using these components separately.36789
What evidence supports the effectiveness of the treatment TBio-4101 + Chemo + IL-2 for skin cancer?
Who Is on the Research Team?
Amod Sarnaik, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
Participants receive cyclophosphamide and fludarabine to prepare for TIL infusion
TIL Infusion
Participants receive TBio-4101 TIL product intravenously
IL-2 Administration
Participants receive interleukin-2 (IL-2) after TIL infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Fludarabine
- Interleukin-2
- TBio-4101
Interleukin-2 is already approved in United States, European Union for the following indications:
- Metastatic melanoma
- Metastatic renal cell carcinoma
- Metastatic renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Turnstone Biologics, Corp.
Industry Sponsor