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:

• People who are at least 18 years old.
• People who have been diagnosed with a specific type of ovarian, peritoneal (abdominal lining), or fallopian tube cancer confirmed by laboratory testing, including serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma subtypes.
• People whose cancer has stopped responding to platinum-based chemotherapy — either because the cancer progressed within 6 months of their last platinum treatment, or because they are unable to tolerate further platinum-based treatment.
• People with a blood marker called CA125 measured at more than twice the upper limit of normal on a specific approved laboratory test at the time of screening.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People who have cancer that can be measured or evaluated on imaging scans according to standard medical criteria.
• People whose blood counts are within acceptable ranges — specifically, a sufficient number of infection-fighting cells (neutrophils), platelets, and red blood cells (hemoglobin).
• People whose kidneys are functioning well enough, based on a standard calculation or a 24-hour urine test.
• People whose liver is functioning within acceptable ranges based on blood tests, with a specific exception allowed for people with a condition called Gilbert's Syndrome.
• People who are expected to live for at least 3 months without treatment.
• People who are willing to have tissue samples (biopsies) taken from a tumour before treatment starts, on day 28 of treatment, and at the end of treatment.
• People who could potentially become pregnant (those who have not had a hysterectomy, removal of both ovaries, tubal ligation, or at least 24 consecutive months of natural menopause) must have a negative pregnancy blood test at screening and before treatment begins, must agree not to breastfeed during the study and for at least 1 year after receiving the study treatment, and must agree to use effective contraception from the time of treatment until at least 1 year afterwards.
• People who are able and willing to attend all required study visits and follow all study requirements.
• People who understand the experimental nature of this study and sign an approved written consent form before any study procedures begin.

Who may not be able to join:

• People who have had significant bleeding (graded as moderate or higher) within the 30 days before screening.
• People whose blood clotting test results (aPTT or INR) fall outside acceptable ranges at screening, unless they are on specific blood-thinning medications (heparin or warfarin) and their levels fall within a defined acceptable window.
• People who are currently taking full-dose blood thinners (anticoagulants) or clot-dissolving medications for treatment purposes, unless they are on a stable low preventative dose for at least 4 weeks with no bleeding complications.
• People who have had a stroke, mini-stroke (TIA), or bleeding in the brain within the 3 months before screening.
• People with known significant neurological conditions, such as untreated brain metastases, active epilepsy requiring ongoing medication, severe nerve or brain disorders, or psychosis.
• People with an active autoimmune disease (where the immune system attacks the body) that requires significant immune-suppressing medication within the past 6 months — though people with well-controlled, stable autoimmune conditions (such as Type 1 Diabetes on stable insulin, treated underactive thyroid, vitiligo, or resolved childhood asthma) may still be eligible (confirm with trial site).
• People who still have unresolved side effects from previous immunotherapy treatments that have not returned to near-normal levels at least 3 months before joining.
• People who have an ongoing serious bacterial, viral, or fungal infection that is not improving with treatment, or who require intravenous antibiotics at the time of screening.
• People who have had another active cancer within the past 2 years, except for certain treated skin cancers or early-stage cancers such as carcinoma in situ of the cervix or breast.
• People whose tumour is causing an urgent medical problem, such as a bowel blockage or major compression of blood vessels, that would prevent them from safely participating.
• People with significant heart conditions, including severe heart failure, poorly controlled chest pain, a heart attack within the past year, serious heart rhythm problems, a history of heart muscle inflammation (myocarditis), moderate-to-severe valve disease, poorly controlled high blood pressure, a history of hypertensive crisis, significant blood vessel disease, or cancer involvement around the heart lining.
• People whose heart pumping function (left ventricular ejection fraction) is below 40% on a heart scan.
• People with a blood protein marker (troponin) above the normal range, unless a heart specialist has reviewed and approved this (confirm with trial site).
• People with low blood oxygen levels (below 92%) while breathing normal room air.
• People with a known history of interstitial lung disease or active non-infectious lung inflammation within the past 5 years.
• People with significant fluid build-up around the heart, lungs, or abdomen that has needed draining for symptom relief within the 28 days before screening.
• People with other serious uncontrolled medical conditions — such as advanced liver disease, recent serious injury, or severe psychiatric illness — that the trial doctor believes could affect safety or the reliability of study results.
• People who have previously received any treatment targeting a protein called MUC16.
• People who have previously received a stem cell transplant from another person (allogeneic transplant).
• People who have previously received any cell therapy or gene therapy.
• People who have received high-dose steroid medications within 72 hours before the procedure to collect immune cells (leukapheresis) or before the study treatment infusion.
• People who have received non-steroid immune-suppressing medications within 2 weeks before leukapheresis.
• People who have received cancer treatments (such as chemotherapy) or radiation therapy within 2 weeks before leukapheresis.
• People who have received a live vaccine within 30 days before joining the trial.
• People with active or inadequately treated Hepatitis A (based on a specific antibody test), Hepatitis B (unless viral levels have been undetectable for at least 6 months with antiviral treatment), or Hepatitis C (unless the virus has been undetectable for at least 6 months).

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