Phase 1 Colorectal 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 who are 18 years of age or older.
• People who are willing and able to give informed consent and follow the study's instructions throughout the trial.
• People who have been diagnosed with colorectal cancer (bowel cancer) and, after having their cancer completely removed by surgery followed by standard follow-up treatment, have no cancer visible on scans but do have detectable cancer DNA fragments circulating in their blood (a sign of possible remaining cancer at a very small scale).
• People who are generally well enough to carry out normal daily activities with little or no limitation (confirm with trial site for exact fitness level required).
• People with a life expectancy of more than 3 months.
• Women who are either not able to become pregnant, or who are able to become pregnant and agree to use contraception during the study and for 6 months after receiving the study treatment.
• Men who agree to use contraception during the study and for 6 months after receiving the study treatment.
• Women who are able to become pregnant and have a negative pregnancy test within 72 hours before starting the chemotherapy preparation phase of the trial.
• People whose blood test results show that their liver, kidneys, blood cells, and clotting function are within acceptable ranges within 10 days before starting the chemotherapy preparation phase.
• People whose heart is pumping effectively, with the heart's pumping function measured at more than 50%.
• People who are breathing comfortably at rest or with only mild effort, and whose blood oxygen level is above 92% while breathing normal room air.
• People who are willing to have required blood samples taken and tissue biopsies done as part of the study.
• People who are willing to stay within approximately a 2-hour drive (around 100 miles) of the trial site for the first 4 weeks after receiving the study treatment.

Who may not be able to join:

• People who have active, measurable cancer visible on scans according to standard imaging criteria.
• People who are pregnant, breastfeeding, or planning to become pregnant at any point from the screening visit through to 6 months after receiving the study treatment.
• People who have received cancer treatment (such as chemotherapy or targeted therapy) within 2 weeks before starting the preparation chemotherapy, or within 3 weeks for those who have received antibody-based cancer treatments.
• People who have not yet recovered from side effects of previous cancer treatments (most side effects should have reduced to mild or returned to their normal baseline level before joining).
• People who have had radiation therapy within 2 weeks before starting the preparation chemotherapy, or who are still experiencing side effects from prior radiation.
• People who have received a live vaccine within 6 weeks before receiving the study treatment, or who would need one within 24 months after. Examples include vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, and certain typhoid vaccines. Note: standard injected flu and COVID-19 vaccines are generally permitted, but nasal spray flu vaccines are not.
• People who have previously received a gene-modified T-cell or NK-cell therapy.
• People who have an immune system condition, or who are taking steroid medications at doses above a certain daily threshold on an ongoing basis.
• People who have had another cancer in the past, unless they completed treatment and have had no sign of that cancer for at least 2 years. Some skin cancers and certain early-stage cancers that were fully removed may not require the 2-year waiting period (confirm with trial site).
• People who have an autoimmune disease (where the immune system attacks the body) that has required treatment with immune-suppressing or disease-modifying medications in the past 2 years. Hormone or gland replacement therapies are generally permitted.
• People who have a history of a specific type of lung inflammation (interstitial lung disease) that needed steroid treatment, or who currently have lung inflammation.
• People who have an active infection that requires treatment with antibiotics, antivirals, or other systemic medications.
• People with a known HIV infection.
• People with a known active or chronic hepatitis B or hepatitis C infection.
• People with a known history of active tuberculosis.
• People with a condition, history, or situation that the treating doctor believes would interfere with participating fully in the study or would not be in the person's best interests.
• People with a known psychiatric illness or substance use disorder that would make it difficult to follow the study requirements.
• People who have had an organ or tissue transplant from another person.
• People who have had a significant heart condition within the 12 months before starting the preparation chemotherapy, such as serious heart failure, unstable chest pain, a heart attack, a stroke, or an irregular heartbeat that caused the heart to pump poorly. Certain medically managed heart rhythm conditions may be permitted (confirm with trial site).
• People with a significant prolongation of a specific heart electrical measurement (QT interval) beyond a set threshold, unless cleared by a heart specialist.
• People with serious bleeding disorders or a high risk of severe bleeding. People with a history of blood clots who are already on appropriate blood-thinning medication may still be eligible (confirm with trial site).

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