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 70 years old (any gender) who have given written consent to participate and are willing to follow the trial procedures
• People diagnosed with a specific type of lung cancer called primary non-small cell lung cancer (NSCLC), at a stage between IIA and IIIB, who have had complete surgical removal of the cancer (called R0 resection)
• People who have had no signs of cancer returning after surgery, and whose blood collection appointment (apheresis) is scheduled within one year of their operation
• People whose previous tests showed no certain gene mutations (such as EGFR or ALK) and no expression of a protein called PD-L1 in their tumor tissue
• People who have already completed one to four cycles of platinum-based chemotherapy before joining the trial
• People who are generally well enough to carry out daily activities with minimal limitations (confirm with trial site), are expected to live at least 12 months, and can attend follow-up visits as required
• People whose blood counts and organ function (including liver, kidneys, and blood clotting) fall within the ranges required by the trial
• People who have suitable veins to allow the blood collection process (apheresis)
• People of childbearing potential (male or female) who agree to use reliable contraception during the trial and for at least one year after the last treatment; female participants must have a negative pregnancy blood test within 7 days before joining, and male participants must not donate sperm from the first treatment until one year after the last treatment

Who may not be able to join:

• People who have taken part in another clinical trial of an experimental treatment or device within the 4 weeks before screening
• People who have received cancer treatments such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within the 4 weeks before screening
• People who have had gene-modified immune cell therapy (such as CAR-T or CAR-NK cells) within the past year, or non-gene-modified immune cell therapy (such as NK or DC cells) within the past six months
• People with serious heart problems, including a heart attack or unstable chest pain within the past 6 months, severe heart failure, uncontrolled irregular heartbeat, blood pressure at or above 150/100 mmHg, abnormal heart rhythm readings on an ECG, or a history of major heart surgery
• People with a history of drug addiction, heavy alcohol use, or substance abuse
• People with active infections requiring treatment, including HIV, syphilis, or active hepatitis A, B, or C
• People with severe autoimmune diseases (such as lupus, rheumatoid arthritis, Crohn's disease, or similar conditions) or immune deficiency conditions, particularly those requiring long-term immune-suppressing medications
• People who have needed immune-suppressing or immune-modifying medications within 28 days before screening, or who would need them during the trial
• People who have previously had an organ transplant, a bone marrow or stem cell transplant from a donor, or are on dialysis
• People who have received a live vaccine within 28 days before screening, or who plan to receive one during the trial
• People who have had major surgery within the 4 weeks before screening
• People with a known allergy to the trial treatment (SDTM001 injection), its ingredients, or a history of reactions to cell-based products
• People with a history of, or currently having, another cancer — except those who have been cancer-free for 5 or more years after curative treatment, or those who have had cured cervical cancer, breast carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin
• People with a mental illness or severe cognitive condition that may affect their ability to give informed consent or understand trial questionnaires
• Women who are currently breastfeeding
• People who the trial investigator considers unlikely to complete visits, follow-ups, or evaluations, or who may otherwise be unsuitable for the trial

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