Printed from Voxsanity (voxsanity.com.au) — NCT07720180 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting
NCT07720180
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who have signed and dated a consent form agreeing to take part in the study.
- People who are willing to follow all study procedures and are available for the full duration of the study.
- Women aged 18 to 80 years.
- People who have been diagnosed with recurring epithelial ovarian cancer (all subtypes are eligible).
- People who have at least one measurable area of disease that can be tracked on scans before surgery, and if only one such area exists before surgery, at least one measurable area must remain after surgery.
- People who are in relatively good general health (able to carry out normal activity with minimal restriction) and whose doctors expect them to live for more than 6 months.
- People whose cancer has come back after at least one prior standard treatment, including those whose cancer returned more than 6 months after completing initial treatment (platinum-sensitive) or less than 6 months after completing initial treatment (platinum-resistant), with specific additional conditions depending on which line of treatment is being considered (confirm with trial site).
- Women who could potentially become pregnant must have a negative pregnancy test at the screening stage.
- People who have had a heart scan (MUGA or ECHO) within the past 6 months showing the heart is pumping adequately (ejection fraction above 45%), and whose heart function meets a specific standard (confirm with trial site).
- People with a history of heart disease, chest pain, or certain heart rhythm problems may still be considered if they pass a cardiac stress test, have adequate heart pump function, and receive clearance from a heart specialist with approval from the lead investigator.
- People who may need lung function testing — this applies to those with a history of heavy smoking (20 or more pack-years), those who stopped smoking within the past 2 years or are still smoking, those with a history of lung inflammation, COPD, or asthma, those with noticeable breathing difficulties on examination, or those who have had fluid drained from around the lungs in the past 3 months — and whose lung function results meet specific minimum values (confirm with trial site).
- People with adequate kidney function based on blood test results meeting specific thresholds (confirm with trial site).
- People with adequate liver function based on blood test results meeting specific thresholds, with slightly different limits allowed for those with a condition called Gilbert's Syndrome or those with liver metastases (confirm with trial site).
- People with adequate blood counts, including haemoglobin of at least 8 g/dL and platelets of at least 75,000 per mm³ before surgery; a blood transfusion is acceptable if levels remain stable afterward.
- People who test positive for a specific EBV (Epstein-Barr virus) antibody on a screening test.
- People who have previously received bevacizumab, cyclophosphamide, and/or pembrolizumab.
- People who have had enough immune cells (called TILs) successfully grown in the laboratory (more than 1 billion cells) before the cell infusion stage.
- Women who could potentially become pregnant must use effective contraception during treatment and for 3 months after the preparative treatment.
- Women who have had a period within the past 12 months and have not had a sterilisation procedure must have a pregnancy blood test within 7 days before treatment.
- People who are in relatively good general health at the time of chemotherapy infusion (confirm with trial site).
- People with a neutrophil count (a type of white blood cell) of at least 1,000 per mm³ at the time of the cell infusion stage.
- People with a platelet count of at least 100,000 per mm³ at the time of the cell infusion stage.
- People with adequate kidney function at the time of the cell infusion stage, meeting specific thresholds (confirm with trial site).
- People with adequate liver function at the time of the cell infusion stage, meeting specific thresholds (confirm with trial site).
- People with adequate blood counts at the time of the cell infusion stage, including platelets of at least 100,000 per mm³ and haemoglobin of at least 8 g/dL.
- People whose blood clotting results fall within an acceptable range at the time of the cell infusion stage (confirm with trial site).
- People who have had a urine test within 14 days before treatment showing no signs of a urinary tract infection.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who currently have a serious active infection requiring intravenous antibiotics, a blood clotting disorder, or a major illness affecting the heart, lungs, or immune system.
- People whose cancer did not respond to initial platinum-based treatment or progressed within 90 days of their last platinum dose.
- People who have previously received a type of immune cell therapy that involved a treatment to reduce their immune system (non-myeloablative lymphodepletion).
- People who test positive for HIV, hepatitis B, HTLV I or II, or certain markers for syphilis; people with hepatitis C must have an undetectable viral load to be considered.
- People who are pregnant or breastfeeding.
- People who need ongoing high-dose steroid medication to suppress their immune system (more than 10 mg per day of prednisone or equivalent).
- People who have an autoimmune disease that requires immune-suppressing medication.
- People with a significant psychiatric condition that, in the investigator's opinion, would prevent them from giving informed consent or would make immunotherapy unsafe.
- People with active, untreated cancer spread to the brain; people with previously treated brain metastases may be considered if treatment was completed more than 28 days before consenting, a recent MRI shows no new or worsening lesions, and no ongoing high-dose steroid treatment is required; people with cancer spread to the lining of the brain (leptomeningeal disease) are excluded regardless of prior treatment.
- People who have had another separate cancer diagnosed within the past 3 years, except for certain early-stage cancers that were treated with surgery alone or have been fully treated and are considered low risk for returning (such as certain skin cancers, early-stage breast lesions, or superficial bladder cancer), as judged by the investigator.
- People with recent evidence of a bowel blockage caused by cancer within the past 60 days, unless the blockage was unrelated to cancer and was surgically corrected more than 28 days before signing consent.
- People with any form of a primary immune deficiency condition (such as severe combined immunodeficiency or AIDS).
- People with a known serious allergic reaction to any of the study medications (including cyclophosphamide, mesna, fludarabine, or IL-2) or to components of the cell product (including DMSO, human serum albumin, or IL-2); allergies to supportive medications may still be manageable if an acceptable alternative exists, as determined by the lead investigator.
- People who are unable to understand and give informed consent.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Brian Orr, MD, Medical University of South Carolina
Phone: 843-792-9321
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 December 2026
Est. completion
1 December 2031
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Dose-limiting toxicity (DLT) incidence; Binary patient level indicator for manufacturing success
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.