Phase 2 Melanoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People with melanoma who have already received standard first-line treatment and whose cancer cannot be surgically removed, has spread to other parts of the body, has progressed, or has come back.
• People whose melanoma tumour tissue has been tested and confirmed to show specific melanoma-related proteins (through a laboratory staining process).
• People who weigh at least 40 kg (approximately 88 pounds).
• People aged 18 to 75 years old at the time of joining the trial.
• People with a life expectancy of at least 8 weeks.
• People who have recovered from serious side effects (grade 3 or 4 non-blood-related) from any previous cancer treatment, with those side effects reduced to a mild-to-moderate level (grade 2 or lower).
• People who have not received blood-stimulating growth factor injections for at least 1 week before a specific blood cell collection procedure.
• People who finished treatment with certain targeted or biological cancer therapies at least 7 days before joining.
• People who finished treatment involving a monoclonal antibody (a specific type of cancer drug) at least 4 weeks before joining.
• People who finished any radiation therapy at least 1 week before joining.
• People with a general health and function score of 70% or higher on the Karnofsky/Lansky scale (a measure of ability to carry out daily activities — confirm with trial site).
• People whose heart is pumping adequately, with a left ventricular ejection fraction (a measure of heart pumping strength) of 40–55% or above (confirm with trial site).
• People whose blood oxygen level is 90% or higher when breathing normal room air.
• People whose liver function tests fall within acceptable ranges, as measured by specific blood tests (ALT, AST, bilirubin, and alkaline phosphatase levels).
• People whose kidney function is within an acceptable range, based on a blood test called serum creatinine.
• People whose blood cell counts meet minimum required levels for white blood cells, neutrophils, lymphocytes, and platelets (not achieved through a blood transfusion).
• People who have melanoma that has spread to the bone marrow may still be considered eligible, as long as their blood counts meet the required levels.
• People (or their legal guardians) who are willing and able to sign an informed consent form.

Who may not be able to join:

• People with serious existing illnesses affecting major organs such as the heart, lungs, or liver, or with significant loss of major organ function (with an exception for certain blood-related side effects from prior treatment).
• People who have untreated cancer spread to the brain or central nervous system (people with previously treated and stable brain involvement for at least 4 weeks may still be considered).
• People who have previously been treated with other genetically engineered CAR T-cell therapies.
• People with an active HIV, Hepatitis B, or Hepatitis C infection, or any other infection that is not under control.
• People who need to take corticosteroids or other medicines that suppress the immune system on an ongoing basis.
• People whose tumour appears to be at risk of blocking the airway.
• People who would be unable to follow the requirements of the trial.
• People whose T cells (a type of immune cell needed for this treatment) cannot be collected in sufficient numbers.

Important: Always verify eligibility with the trial site directly before applying.