Phase I/II Study of CD40L-Enhanced TIL Therapy for Advanced Melanoma Patients

Inclusion Criteria

• Have advanced melanoma that cannot be surgically removed or has spread, including specific types like cutaneous, mucosal, or ocular melanoma.
• Have tried at least one standard treatment without success or cannot tolerate it.
• Be at least 18 years old. Patients over 65 may need a heart evaluation to ensure they are at low risk for treatment.
• Have a good overall health status, with a performance score of 0 or 1.
• Have adequate organ and bone marrow function.
• Test negative for HIV, hepatitis B, and hepatitis C (or have controlled hepatitis C).
• If brain metastases are present, they must be treated and stable for at least 4 weeks.
• Women of childbearing potential must have a negative pregnancy test and agree to use birth control during and after the study.
• Be able to understand and sign a consent form.
• Have at least one tumor that can be surgically removed for TIL preparation and another measurable tumor for response assessment.

Exclusion Criteria

• Have a history of heart disease or significant heart rhythm problems unless cleared by a cardiologist.
• Have immune system disorders or are HIV positive.
• Be pregnant or breastfeeding.
• Be taking high doses of steroids or other immunosuppressive medications.
• Have severe allergies to study medications.
• Have poor heart or lung function.
• Have a medical condition that poses a high risk for study participation.
• Have active infections requiring antibiotics.
• Have active autoimmune diseases needing treatment with high-dose steroids or other immunosuppressive drugs.
• Have received prior live cell therapy without special permission from the study investigator.