Early Phase 1 Kidney 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 have read, understood, and signed a consent form agreeing to take part in the study voluntarily
• People aged 18 or older but under 70, of any gender
• People who have been confirmed by laboratory testing to have advanced kidney cancer (renal cell carcinoma) that tests positive for a protein called CD70, and who have already received at least one VEGF-targeted treatment and one immunotherapy treatment (either together or one after the other)
• People who have at least one measurable tumour spot no larger than 6 cm across, as measured by standard imaging criteria
• People whose doctors expect them to live for at least 12 weeks
• People with a physical functioning score (ECOG) of 2 or below, meaning they are able to care for themselves even if they cannot do heavy physical work
• People whose blood counts are within acceptable ranges — including white blood cells, red blood cells, platelets, and lymphocytes — without needing a transfusion or certain blood-boosting treatments in the 7 days before testing
• People whose liver is working well enough, based on blood test results within acceptable ranges (slightly higher limits may apply if cancer has spread to the liver)
• People whose kidneys are working well enough, based on blood test results or a kidney function calculation
• People whose heart pumping function (measured by an echocardiogram) is at least 50%
• People who do not have shortness of breath at rest and whose blood oxygen level is above 93% without needing supplemental oxygen
• People whose blood clotting measures are within acceptable ranges
• People who have suitable veins for a blood-collection procedure called apheresis, with no other reasons preventing this procedure
• Women of childbearing age who have a negative pregnancy test, and all participants who agree to use effective contraception from the time of signing the consent form until 12 months after the last dose of the study treatment

Who may not be able to join:

• People who have previously received any CAR-T cell therapy or other genetically modified T cell treatment
• People who have had a stem cell transplant from a donor or a solid organ transplant, or who are waiting for an organ transplant
• People who currently have a serious or uncontrolled active infection requiring intravenous (drip) antibiotic treatment (those taking antibiotics to prevent infection may still be considered at the investigator's discretion)
• People with active hepatitis B, active hepatitis C, active syphilis infection, or HIV
• People with abnormally low blood sodium or blood potassium levels that cannot be corrected before joining the study
• People whose imaging shows that tumour has replaced 50% or more of their liver
• People with uncontrolled fluid build-up in body cavities (such as the chest or abdomen) that the investigator considers unsuitable
• People who have previously received any treatment specifically targeting the CD70 protein
• People who have been taking ongoing systemic steroid medications above a low dose threshold within 14 days before the blood collection procedure or within 3 days before the cell therapy (routine topical steroid use may be an exception)
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild level (with some exceptions such as hair loss and skin pigmentation changes)
• People who have not yet completed a required waiting period after their most recent cancer treatments, including chemotherapy, targeted therapy, radiation, immunotherapy, or experimental treatments (the required gap varies by treatment type, from 2 weeks up to 4 weeks)
• People who currently have, or have previously had, another type of cancer, with limited exceptions for certain skin cancers, early-stage cancers, or cancers considered fully treated and disease-free for at least five years
• People who have had brain or spinal cord tumours in the past, unless the condition has been stable for at least 4 weeks after treatment, with no current symptoms and no need for medication to control it for at least 14 days
• People with other serious nervous system conditions such as seizures, bleeding in the brain, or dementia, if the investigator considers these a safety concern
• People with uncontrolled high blood pressure, unstable chest pain (angina), severe heart failure, significant abnormal heart rhythm or heart electrical readings, or a heart attack within the past 6 months
• People with serious lung conditions such as interstitial lung disease, active tuberculosis, or a history of extensive radiation to the lungs, if the investigator considers these unsuitable
• People with active or previously recurring autoimmune diseases (such as lupus or rheumatoid arthritis), with exceptions for conditions like type 1 diabetes, underactive thyroid managed with hormone therapy, or certain skin conditions not requiring systemic treatment
• People with any other serious or uncontrolled illness, complex medical condition, or tumour-related circumstance that the investigator believes would make participation unsafe or interfere with evaluating the treatment
• People who have had major surgery or serious injury within 4 weeks before the blood collection procedure, or who have major surgery planned during an early observation period, or who have not fully recovered from a previous procedure
• People who are known to be allergic or intolerant to medicines that may be used during the study, including fludarabine, cyclophosphamide, or tocilizumab, or to any ingredients in the CAR-T cell product, or who have a history of severe allergic reactions such as anaphylactic shock
• Women who are pregnant, planning to become pregnant during the trial, or who are currently breastfeeding
• People who the investigator believes will be unable or unwilling to follow the study requirements
• People who were involved in planning or running this research study

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