Phase 1 Lung 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 aged 18 to 75 years old at the time of signing the consent form
• People whose general physical functioning is rated at a level indicating they are able to care for themselves and carry out light activity (confirm with trial site regarding the specific rating scale used)
• People with a life expectancy of at least 12 weeks
• People who have at least one measurable tumour that can be detected on a CT scan or MRI taken within 28 days before the blood collection procedure
• People who can provide either a stored tumour tissue sample or a fresh biopsy to test for a specific protein called DLL3
• People whose blood counts, liver, kidney, clotting, and heart function meet the required levels as measured by blood and urine tests (confirm specific values with trial site)
• People whose heart pumping function is at least 50% and whose heart classification meets the required level (confirm with trial site)
• People who have suitable veins for a blood cell collection procedure
• Women of childbearing potential who are not pregnant or breastfeeding, and who have a negative pregnancy blood test during screening
• People of childbearing potential, including men whose partners could become pregnant, who agree to use medically acceptable contraception throughout treatment and for 2 years after the last treatment dose, or until a specific test comes back negative, whichever is later
• Men who agree not to donate sperm, and women who agree not to donate eggs, throughout treatment and for 2 years after the last treatment dose, or until a specific test comes back negative, whichever is later
• People who are willing and able to follow the study plan, attend required visits, and communicate with the study team
• People who have read, understood, and signed the consent form before any study-related procedures begin

Who may not be able to join:

• People who are pregnant, breastfeeding, or who have a positive pregnancy test during the screening period
• People who have received a live vaccine within 4 weeks before the blood collection procedure, or who plan to receive any vaccine (other than a COVID-19 vaccine) during the study
• People with a history of immune system deficiency conditions, or who have had an organ or bone marrow transplant
• People who have had a serious blood clot or stroke event within 6 months before the blood collection procedure, such as a deep vein clot, pulmonary embolism, or brain bleed (certain exceptions may apply — confirm with trial site)
• People who have an inherited or acquired bleeding or clotting disorder, such as haemophilia or an enlarged spleen
• People with certain heart rhythm abnormalities detected during screening, or a personal or family history of specific heart rhythm conditions, or who have had a heart attack or heart surgery within the past 6 months
• People with other serious health conditions that could affect their safety or their ability to complete the study, such as an unhealed stomach ulcer, bowel blockage, lung scarring, kidney failure, or uncontrolled diabetes
• People who have an active infection currently requiring intravenous antibiotic or antiviral treatment (participation may be possible 2 weeks after completing that treatment — confirm with trial site)
• People with a history of autoimmune nervous system disorders such as multiple sclerosis, myasthenia gravis, or Guillain-Barré syndrome, or active autoimmune or inflammatory conditions such as lupus, inflammatory bowel disease, or rheumatoid arthritis (some specific exceptions may apply — confirm with trial site)
• People with a known serious allergic reaction to cyclophosphamide or fludarabine (medications used in this trial), or to human serum albumin or dimethyl sulfoxide
• People with active or chronic infections including active hepatitis B, hepatitis C, HIV, or syphilis (as defined by specific test results — confirm with trial site)
• People who have previously received CAR-T cell therapy or other gene-editing cell therapies
• People who have participated in another clinical trial within 28 days before screening
• People who have used oral or intravenous corticosteroids at a daily dose of 10 mg or more within 7 days before the blood collection procedure (inhaled steroids are an exception)
• People who have received chemotherapy, immunotherapy, or targeted cancer therapy within 4 weeks before the blood collection procedure, or within a timeframe based on the specific drug's duration in the body, whichever is shorter
• People who have received certain types of radiotherapy within 4 weeks before the blood collection procedure, or local palliative radiotherapy within 2 weeks before
• People who have received certain traditional Chinese medicine treatments for cancer within 2 weeks before the blood collection procedure
• People who still have side effects from previous cancer treatments that have not resolved to a mild or absent level (with some exceptions such as hair loss — confirm with trial site)
• People who previously had to stop a treatment due to serious immune-related side effects such as lung inflammation, or pituitary, thyroid, or pancreas problems caused by that treatment
• People who have had major surgery or an interventional procedure within 4 weeks before the blood collection procedure and have not fully recovered (routine tumour biopsy and fluid drainage are exceptions)
• People with evidence of interstitial lung disease or active lung inflammation
• People whose small cell lung cancer has undergone a specific type of transformation (confirm with trial site)
• People with symptomatic fluid build-up around the lungs, in the abdomen, or around the heart that requires draining (some exceptions may apply — confirm with trial site)
• People with brain metastases or cancer that has spread to the lining of the brain or spinal cord (some exceptions for previously treated and stable brain metastases may apply — confirm with trial site)
• People who have had another cancer diagnosis within the past 5 years, unless that cancer is considered to have been fully treated and cured (certain early-stage or skin cancers may be exceptions — confirm with trial site)
• People who, in the trial doctor's assessment, have any other medical, physical, or test finding that makes participation unsafe or unsuitable
• People who, in the trial doctor's assessment, are unlikely to be able to follow the study requirements
• People with a history of, or currently diagnosed with, an uncontrolled psychiatric condition

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