Phase 1 Stomach 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 or older who are willing and able to give written consent before any study procedures begin.
• People who are able and willing to attend all required study visits and follow the study requirements.
• People whose cancer-related physical condition is rated as fully active or restricted only in physically strenuous activity (as measured by a standard medical performance scale called ECOG 0 or 1).
• People with a life expectancy of at least 12 weeks.
• People who have a confirmed diagnosis (through tissue or cell testing) of a cancer that cannot be surgically removed or has spread, and whose cancer has stopped responding to standard treatments — or who cannot receive standard treatments, or for whom no standard treatment exists. Tumour types of particular interest include breast, stomach, and endometrial (uterine lining) cancers, though other solid tumours may be considered by the study doctor based on current research.
• People whose tumour tests strongly positive for a protein called HER2 (specifically a score of 3+ on a standardised laboratory test performed in a certified lab).
• People whose cancer has at least one measurable area of disease, as assessed by standard imaging guidelines (RECIST v1.1).
• People whose blood counts and organ function meet all of the following levels, as confirmed by blood tests:
  • Red blood cell levels (haemoglobin) of at least 9.0 g/dL
  • A sufficient number of infection-fighting white blood cells (neutrophils), without the need for medication to boost them
  • Platelet count of at least 100 x10⁹/L
  • Blood clotting times within an acceptable range (or stable if on blood-thinning medication)
  • Liver enzyme levels within acceptable limits (slightly higher limits apply if cancer has spread to the liver)
  • Bilirubin (a liver-related substance) below 2 mg/dL (a slightly higher limit applies for people with a condition called Gilbert's Syndrome)
  • Kidney function within an acceptable range, based on blood creatinine levels or a calculated kidney function score
• People who test negative for HIV.
• People who do not have active hepatitis B or hepatitis C infection (certain people with a past hepatitis B infection or a past hepatitis C exposure may still be eligible — confirm with trial site).
• People who test negative for active tuberculosis, syphilis, herpes simplex virus, cytomegalovirus, HTLV, and Epstein-Barr virus.
• People whose heart pumping function (LVEF) is at least 50%, as confirmed by a heart scan.
• People whose lung function test results (FEV1, FVC, and DLCO) are all at least 50% of the expected normal values.
• People who are able to use highly effective contraception during the study and for at least 12 months after receiving the study treatment (applies to people who could become pregnant, or whose partners could become pregnant).
• Women who are not pregnant and not breastfeeding, and who either cannot become pregnant or agree to use contraception with a failure rate of less than 1% per year from screening until 12 months after receiving the study treatment. A negative blood pregnancy test within one week before the first treatment is also required for women who could still become pregnant.
• Men who agree to use contraception or remain abstinent during treatment and for at least 6 months after the last dose, to refrain from donating sperm during the study, and to notify the study team if their partner becomes pregnant.
• People whose specially prepared immune cells (called p95HER2.CAR-TECH2Me T cells) have been successfully grown in the laboratory to the required level before the preparatory chemotherapy begins.
• People whose side effects from any previous cancer treatments have recovered to a mild level (grade 1 or lower) at least 4 weeks before enrolling, with some exceptions allowed (confirm with trial site).
• People who have had a minor surgical procedure within the past 3 weeks, provided any related side effects have recovered to a mild level.

Who may not be able to join:

• People with brain metastases (cancer that has spread to the brain) that are causing symptoms or have not been treated. People with fully treated, stable brain metastases may be considered after discussion with the medical team (confirm with trial site).
• People whose cancer has spread to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis).
• People who currently have, or have been diagnosed within the past 3 years with, another invasive cancer — with some exceptions such as certain low-risk or treated cancers (confirm with trial site).
• People who have an active serious infection requiring antibiotic or antiviral treatment within 14 days before the preparatory chemotherapy.
• People with active hepatitis B or hepatitis C infection.
• People with an active autoimmune disease that requires immune-suppressing medication.
• People who have previously had an organ transplant or bone marrow transplant.
• People with a primary immune system disorder (such as Severe Combined Immunodeficiency Disease or AIDS).
• People who regularly need to take steroid medications (inhaled or skin-applied steroids, and low-dose replacement steroids, are generally permitted — confirm with trial site).
• People with a significant, ongoing, or poorly controlled disease affecting the kidneys, liver, blood, hormone systems, lungs, heart, digestive system, or nervous system, currently or within the past 6 months.
• People with a history of procedures to open blocked heart arteries (coronary revascularisation) or symptoms of reduced blood flow to the heart.
• People with a history of idiopathic pulmonary fibrosis (scarring of the lungs with no known cause), or signs of active lung inflammation from any cause.
• People who are allergic to any ingredient in the study treatment products.
• People who cannot safely receive the preparatory chemotherapy drugs (cyclophosphamide and fludarabine) at the doses required by the study.
• People who have received cancer treatments — including chemotherapy, radiation therapy, or certain targeted therapies — within 4 weeks before the preparatory chemotherapy (some exceptions apply for certain bone-related treatments and hormone therapies — confirm with trial site).
• People who have received certain non-chemotherapy cancer drugs or targeted therapies within 4 weeks before the preparatory chemotherapy (or within five half-lives of the drug, whichever is sooner).
• People who have received any other experimental treatment within 4 weeks before the preparatory chemotherapy (or within five half-lives of the treatment, whichever is sooner).
• People who have received a live or weakened (attenuated) vaccine within 4 weeks before the preparatory chemotherapy.
• People who have had major surgery within 3 weeks before the preparatory chemotherapy.
• People who have previously received any experimental cell or gene therapy.
• Women who are pregnant or breastfeeding.
• People whose personal, family, social, or geographical circumstances may make it difficult to follow the study schedule and requirements.
• People with any other serious medical condition or abnormal test result that the study doctor considers would increase the risks of participation.

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