Phase 1 Ovarian 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:

• Adults aged 18 or older.
• People with an advanced or spreading gynaecological cancer that has been confirmed by a tissue or cell sample, and whose tumour tests positive for a protein called CD70 (at a level called IHC 3+).
• People whose cancer has stopped responding to standard treatments (such as surgery, chemotherapy, radiotherapy, or targeted therapy), or who were unable to tolerate those treatments, and for whom no other effective treatment is currently available.
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines called RECIST v1.1, and that has not already been treated with local therapy.
• People with a general health and activity level rated as 0, 1, or 2 on a standard scale called ECOG (meaning able to carry out at least some daily activities).
• People whose doctors expect them to live for more than 12 weeks.
• People without serious mental health disorders.
• People whose major organs are functioning at an acceptable level, including: blood cell counts, heart function (with a pumping strength of at least 50% on an ultrasound), kidney function, liver function, and blood oxygen levels above 92% without extra oxygen.
• People who are able to have blood drawn or cells collected, with no medical reasons preventing this.
• People who agree to use a reliable form of contraception (not the rhythm/safe period method) from signing the consent form until one year after receiving the cell treatment.
• People (or their legal guardian) who agree to take part in the trial and sign a consent form after being informed of its purpose and procedures.

Who may not be able to join:

• People who have previously received any treatment targeting CD70.
• People who currently have active or symptomatic cancer spread to the brain or the lining of the brain; people who had brain metastases treated may only be considered if scans show no sign of new growth for at least 4 weeks after that treatment ended.
• People who took part in another clinical trial using an unapproved drug within 3 months before the cell infusion, or who used an approved drug within 5 half-lives of the cell infusion.
• People who received chemotherapy or targeted therapy within 2 weeks (or within 5 half-lives, whichever is shorter) before cell collection; whole-body radiation within 4 weeks; local radiation within 2 weeks; or radioactive drugs such as strontium or samarium within 8 weeks before treatment.
• People who took steroid medicines (such as prednisone) at a dose greater than 10mg per day within 2 weeks before cell collection, unless the steroids were inhaled, applied to the skin, or used as a low-dose hormone replacement (confirm with trial site for exceptions).
• People who received a live vaccine within 4 weeks before screening.
• People who have an active or uncontrolled infection requiring treatment throughout the whole body within 1 week before screening.
• People who have had a different cancer within the past 3 years, unless that cancer was fully treated with no sign of return for at least 3 years, or it was a type of non-melanoma skin cancer that was fully treated with no current evidence of disease.
• People with significant heart problems, including: severe heart failure (NYHA Stage III or IV); a heart attack or heart bypass surgery within the past 6 months; a history of serious irregular heartbeats or unexplained fainting (not caused by dehydration or a simple vasovagal episode); or a history of severe non-ischemic heart muscle disease.
• People with known active or uncontrolled autoimmune diseases, such as Crohn's disease, rheumatoid arthritis, lupus, or systemic vasculitis.
• People who test positive for active Hepatitis B virus, active Hepatitis C virus, HIV, syphilis, or active cytomegalovirus (CMV).
• People who have a history of blood clots in the veins (such as a pulmonary embolism) and currently need blood-thinning medication, or who have had ongoing severe bleeding or lasting complications from a blood clot (confirm with trial site, as some people with a clot history may still be considered).
• People with poorly controlled high blood pressure (systolic at or above 150mmHg and/or diastolic at or above 90mmHg) that cannot be brought under control with medication before screening.
• People who are pregnant or breastfeeding, or people who plan to start a family within one year of receiving the cell treatment.
• People who the trial doctors consider unsuitable for participation for any other reason.

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