Phase 1 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 who are 18 years of age or older.
• People who are willing and able to give informed consent to participate.
• People who have a specific genetic marker called HLA A*02:01 (a blood test can confirm this).
• People who have been diagnosed with advanced, inoperable, or spreading melanoma (skin, mucosal, or unknown primary type) that has returned or stopped responding to certain immunotherapy treatments, including anti-PD-1 therapy, with or without other checkpoint-blocking drugs — and who have received no more than 3 prior rounds of these immunotherapy treatments in the metastatic setting.
• People who have received at least one prior systemic (whole-body) cancer treatment.
• People who are generally well enough to carry out light daily activities, as measured by a standard medical scoring system (ECOG score of 0 or 1).
• People with a life expectancy of at least 3 months.
• People whose cancer can be measured on scans using standard criteria (called RECIST).
• People whose heart, lungs, and other organs are functioning adequately, as confirmed by tests done within 10 days before starting treatment.
• People whose heart pumps blood at greater than 50% efficiency (confirmed by a heart scan).
• People who have no significant breathing difficulties at rest and whose blood oxygen level is above 92% on room air.
• Women who are not able to become pregnant, OR women who could become pregnant and agree to use contraception during the study and for 6 months after receiving the cell infusion, and who immediately notify their doctor if pregnancy is suspected.
• Men who agree to use contraception during the study and for 6 months after the cell infusion, and who immediately notify their doctor if a pregnancy occurs or is suspected.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the preparatory chemotherapy.
• People who are willing to have blood samples taken and tissue biopsies done as required by the study.
• People who agree not to receive any live vaccines for at least 24 months after receiving the cell infusion.
• People who agree to sign consent for long-term follow-up as part of a related protocol.

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study period or within 6 months after the cell infusion.
• People who have received systemic cancer treatment too recently before starting the preparatory chemotherapy (within 2 weeks or 5 half-lives of most treatments, or within 3 weeks for antibody-based treatments).
• People who have not yet recovered from significant side effects of previous cancer treatments (minor ongoing side effects such as mild nerve symptoms or hair loss may be considered on a case-by-case basis by the lead doctor).
• People who have had radiation therapy within 2 weeks before starting the preparatory chemotherapy, or who have not recovered from radiation-related side effects.
• People who have received a live vaccine within 6 weeks before the cell infusion (examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, and typhoid; nasal flu spray is also not allowed, but injected flu and COVID-19 vaccines generally are).
• People with an immune system disorder or who are taking regular steroid medication at doses above a certain level (equivalent to more than 10 mg of prednisone per day).
• People with a history of another cancer, unless treatment was completed at least 2 years ago with no sign of return (some early-stage or fully removed skin and superficial cancers may be exempt — confirm with trial site).
• People with active brain metastases or cancer that has spread to the lining of the brain. People with previously treated and stable brain metastases who no longer need steroid treatment may be considered (confirm with trial site).
• People with an active autoimmune disease that has needed systemic medical treatment in the past 2 years (simple hormone replacement therapies such as thyroid or insulin are generally allowed).
• People who currently need ongoing immune-suppressing medications.
• People with a lung condition called interstitial lung disease that is causing symptoms or could complicate monitoring of lung-related side effects.
• People with an active infection such as COVID-19, influenza, or recent serious blood infection. People who have fully recovered from an infection may be considered.
• People with a known HIV infection, or active or chronic hepatitis B or hepatitis C infection.
• People with a medical or mental health condition, or medication history, that the treating doctor believes could affect the study results or make participation unsafe.
• People with a known psychiatric condition or substance use disorder that would make it difficult to follow the study requirements.
• People who have previously received an organ or tissue transplant from another person.
• People who have had serious heart or blood vessel problems within the past 12 months, such as heart failure, heart attack, stroke, unstable chest pain, or a heart rhythm problem that caused instability (a medically controlled heart rhythm condition may be acceptable — confirm with trial site).
• People with a significantly prolonged heart electrical reading (QTc interval greater than 480 milliseconds) on an ECG.
• People with serious bleeding or clotting disorders, or who are at high risk of severe bleeding. People with a history of blood clots who are already on appropriate blood-thinning treatment may still be eligible (confirm with trial site).
• People with a blood marker called LDH that is more than 2.5 times the upper limit of normal on testing done at screening.

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