Phase 2 Endometrial Cancer 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 whose cancer has been confirmed by laboratory testing to be from a specific primary tumor site and stage listed in the trial's protocol.
• People whose tumor has been tested in a certified laboratory and confirmed to carry the HPV16 strain of the human papillomavirus.
• People who have been tested in a certified laboratory and confirmed to carry a specific immune system gene marker called HLA-A*02:01 (this must be fully confirmed before a blood collection procedure called apheresis takes place).
• People whose cancer can be measured using standard imaging criteria (known as RECIST 1.1 or PERCIST).
• People aged 18 or older.
• People who are generally well enough to carry out daily activities with little or no limitation, as assessed by a standard health scoring tool (ECOG score of 0 or 1).
• Women under 55, or any woman who has had a menstrual period in the last 12 months, must have a negative pregnancy test (this is not required for women who have had both ovaries or their uterus removed).
• People who agree to use effective contraception before joining the trial and for four months after treatment, and who agree to notify their doctor immediately if pregnancy occurs or is suspected during the trial.
• People who test negative for HIV, hepatitis B, and hepatitis C (if a hepatitis C antibody test comes back positive, a further test must confirm there is no active infection).
• People whose blood test results show that their immune cells, platelets, red blood cells, liver function, kidney function, and blood clotting are all within the ranges required by the trial.
• People who are able to understand and are willing to sign a written consent form.
• People who agree to take part in two related Rutgers University studies — one for long-term follow-up of gene therapy participants, and one involving biological sample collection.

Who may not be able to join:

• People who have previously received systemic (whole-body) treatment or definitive chemotherapy combined with radiation for the cancer being studied in this trial (palliative radiation given only to manage symptoms is permitted).
• People currently receiving treatment in another clinical trial involving an experimental therapy.
• People with a history of severe allergic reactions to substances similar to those used in this trial.
• People with uncontrolled ongoing illness at the time of treatment, such as an active serious infection, uncontrolled heart failure, unstable chest pain, irregular heart rhythm, or a psychiatric or personal situation that would make it difficult to follow the trial's requirements.
• People whose cancer has a specific genetic change (a damaging mutation or loss in the HLA-A*02:01 gene) detected by clinical or research testing.
• People whose heart pumping function (measured as LVEF) is 45% or below — certain participants, including those aged 50 or older or those with significant heart rhythm problems, will be assessed with a heart evaluation test.
• People whose blood oxygen level is at or below 92% while breathing normal room air (a re-evaluation may be possible if the underlying cause improves).
• People who are currently breastfeeding, as there is an unknown but potential risk to infants if the mother receives this treatment.
• People with a weakened immune system, including those with HIV or a primary immune deficiency condition such as Severe Combined Immunodeficiency Disease.
• People currently taking immune-suppressing medications, including corticosteroids, unless specific criteria outlined in the trial protocol are met.
• People with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or lupus (people with milder autoimmune conditions such as hypothyroidism or vitiligo may still be eligible).
• People with another current or past cancer that could interfere with the safety or results of this trial (some lower-risk cancers, such as certain skin cancers or early-stage conditions, may not exclude someone — confirm with the trial site).
• People who received a live vaccine within the 30 days before enrolling.
• People where the lead trial investigator determines that participation would not be in the person's best interest or could affect their safety or the reliability of the trial data.

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