Printed from Voxsanity (voxsanity.com.au) — NCT07553390 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Breast Cancer Trial, Not Yet Recruiting
NCT07553390
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 been diagnosed with breast cancer (confirmed through tissue testing) that has spread or cannot be surgically removed, and where standard treatments no longer exist or are no longer working.
- People who have at least one tumour or affected area that is large enough to be measured by imaging or physical exam (at least 2 cm on chest x-ray, or at least 1 cm on CT scan, MRI, or physical measurement).
- People who are 18 years of age or older.
- People with triple-negative breast cancer (a specific subtype where the tumour lacks certain receptors) who have previously received at least one dose of a medicine called Sacituzumab govitecan or a similar type of drug targeting a protein called TROP2.
- People who had their last chemotherapy, targeted therapy, or similar cancer treatment at least 2 weeks before the start of the preparatory chemotherapy used in this trial.
- People who received any previous cell-based cancer therapy at least 3 months before joining (this requirement does not apply to repeat treatments within the trial).
- People who have received localised radiation to one or more tumour sites before the trial's preparatory chemotherapy, provided there are other non-irradiated tumour sites that can still be measured.
- People who have a good general level of physical functioning, rated as fully active or restricted only in physically strenuous activity (confirm with trial site for exact scoring criteria).
- People whose kidneys are functioning adequately, as assessed by a specific blood test showing a filtration rate of at least 50 ml/min/1.73 m² (confirm with trial site).
- People whose liver is functioning adequately, with liver enzyme levels within acceptable ranges and no history of liver cirrhosis (confirm with trial site for specific values).
- People whose heart is functioning adequately, with the heart pumping at least 50% of its capacity, no significant fluid around the heart, and no serious heart rhythm problems (certain well-controlled conditions may be acceptable — confirm with trial site).
- People whose lungs are functioning adequately, with no significant fluid around the lungs, blood oxygen levels of at least 92% while breathing normal air, and no active lung inflammation requiring steroid treatment.
- People whose blood counts and clotting levels are within acceptable ranges, including sufficient white blood cells, platelets, and haemoglobin (confirm with trial site for specific values).
- People who are able to understand and sign a written consent form.
- People who weigh at least 40 kg.
- Women who are not able to become pregnant, or women who are able to become pregnant and agree to use effective contraception during the study treatment period and for 6 months after receiving the trial treatment.
- Women who are able to become pregnant must have a negative pregnancy test within 72 hours before starting the preparatory chemotherapy.
- Women who are able to become pregnant and men must agree to use effective contraception before joining the study and for the full duration of their participation, and for 6 months after receiving the trial cell infusion; male participants who father or suspect they have fathered a child during the study must notify their doctor immediately.
- People who are willing to have blood samples taken and tissue biopsies performed as required by the study.
- People who are willing to consent to long-term follow-up as part of a separate related study protocol.
- People who are willing to remain within approximately a 2-hour drive (about 100 miles) of the study site during the first 4 weeks after receiving the trial treatment.
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 have ongoing significant side effects (Grade 2 or higher) from previous cancer treatments that have not resolved to a mild level or disappeared before the preparatory chemotherapy begins.
- People who have an active fungal, bacterial, viral, or other infection that requires intravenous antibiotics or is not responding to treatment (simple urinary tract infections or straightforward throat infections that are responding to treatment may be acceptable).
- People with a known active hepatitis B or hepatitis C infection.
- People who are known to have HIV.
- People who have an active neurological (brain or nervous system) disorder.
- People who have had an active autoimmune disease (where the immune system attacks the body) within the past 12 months, with the exception of mild psoriasis or well-controlled thyroid autoimmune conditions.
- People who have a condition called amyloidosis or POEMS syndrome.
- People whose cancer has spread to the brain or spinal cord in a way that is causing symptoms or is not well controlled, or who show signs of spinal cord compression (if radiation has been given for this, a waiting period of at least 14 days is required).
- People who have had another cancer in the past 2 years, with some exceptions for certain early-stage or fully treated skin cancers, cervical cancer without recurrence, or certain low-risk cancers that the investigator does not consider likely to interfere with trial participation (confirm with trial site).
- People who have serious heart conditions, including severe heart failure, a heart attack or stroke within the past 26 weeks, unstable chest pain within the past 13 weeks (unless treated with a procedure such as a stent), severe narrowing of the aortic heart valve, uncontrolled irregular heart rhythm, a genetic condition affecting heart rhythm called long QT syndrome, or a specific abnormal heart electrical reading on testing (confirm with trial site for details).
- People who have had major surgery within 4 weeks before the first dose of the preparatory chemotherapy.
- People who are currently taking part in another clinical trial involving an experimental treatment.
- People who are currently receiving other cancer treatments.
- People who are currently taking steroid medications by mouth or injection at levels above a low daily dose, with exceptions for steroids applied to the skin, eyes, nose, or inhaled by breath (confirm with trial site for specific dose thresholds).
- People who have received certain immune-suppressing antibody treatments (anti-thymocyte globulin within 14 days, or alemtuzumab within 28 days) before joining.
- People who are currently taking medications that suppress the immune system.
- People who are pregnant or breastfeeding.
- People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, or others) within 6 weeks before the trial cell infusion; most standard flu and COVID-19 injections are generally permitted, but nasal spray flu vaccines are not.
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: Bora Lim, MD, UT MD Anderson
Phone: (713) 745-0689
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 1
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2026
Est. completion
30 March 2036
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety and Adverse Events (AEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.