Phase 2 Brain 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:

• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use acceptable birth control for the full duration of the study and until the study drug is no longer detectable in the blood (which may be several years); a combination of two birth control methods is recommended
• Women who are able to become pregnant must have negative pregnancy tests at screening, within 72 hours before a blood collection procedure called leukapheresis (if more than 72 hours have passed since screening), before every treatment cycle, at the end of treatment, and whenever pregnancy is suspected
• People with a confirmed diagnosis of triple negative breast cancer (TNBC) or hormone receptor-positive (HR+) breast cancer, both with HER2-negative results confirmed by standard laboratory testing
• People who have at least one brain metastasis (cancer spread to the brain) that has not been treated, is between 0.5 cm and less than 3.0 cm in size, is not causing symptoms, and does not require immediate local treatment — as assessed and approved by the research team
• People whose brain metastases of 3.0 cm or larger, or those causing symptoms, have already been treated with radiation or surgery before joining the study
• People who have had prior radiation therapy (SRS) at least 2 weeks before the first vaccine dose, or whole brain radiation or brain surgery at least 4 weeks before, with at least one untreated lesion remaining to serve as a target
• People who have recovered adequately from any major surgery before starting treatment
• People with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 — meaning they are fully active or have only minor restrictions in physical activity (confirm with trial site)
• People with side effects from prior treatments that have settled to a mild level (Grade 1 or below), with an exception for mild-to-moderate nerve-related side effects (Grade 2 or below)
• People whose blood and organ function results, tested within 10 days before starting treatment, meet all of the following levels: haemoglobin at least 9 g/dL, white blood cell count at least 3 × 10⁹/L, neutrophil count at least 1.5 × 10⁹/L, platelets at least 100 × 10⁹/L, liver function values within acceptable ranges, kidney function within acceptable ranges, and normal blood clotting levels (or within the safe range if already on blood-thinning medication)
• People with no evidence of cancer spread to the lining around the brain and spinal cord (leptomeningeal disease)
• People taking steroids only at a low dose of 10 mg of prednisone per day or less
• People with a life expectancy of more than 3 months
• People who have previously received checkpoint inhibitor treatments, provided the last dose was at least 3 weeks before joining the study
• People whose cancer has progressed on current treatment in the brain may continue certain existing treatments (such as HER2-directed antibodies, hormone therapies, or specific chemotherapy agents) while on the study, at the treating doctor's discretion

Who may not be able to join:

• People with brain metastases that are currently causing symptoms, unless those symptoms have fully resolved after local treatment before the study drugs are given
• People currently taking part in another clinical trial or who have used an investigational treatment or device within 4 weeks before the first vaccine dose
• People who have received chemotherapy or certain targeted therapies (other than those specifically allowed in the inclusion criteria) within 4 weeks or 5 half-lives (whichever is sooner) before starting treatment, or who have not recovered from side effects of prior treatment
• People whose cancer is progressing rapidly in the body in a way that may prevent completion of all vaccine doses
• People with an active autoimmune disease that has required systemic treatment (such as immune-suppressing medications) within the past 2 years; hormone or gland replacement therapies are generally not considered a reason for exclusion (confirm with trial site)
• People who have had an organ or tissue transplant from another person
• People with an active infection currently requiring systemic treatment that the investigator believes would increase risk
• People with a known active hepatitis B or hepatitis C infection
• People with a known immune-suppressing condition such as HIV or AIDS
• People who have received a blood transfusion within two weeks before the leukapheresis procedure
• Women who are pregnant or currently breastfeeding (women who agree to stop breastfeeding may still be considered eligible — confirm with trial site)
• People who are unwilling or unable to follow the study requirements
• People with a brain lesion causing a significant shift of brain structures or blockage of fluid flow in the brain
• People requiring corticosteroids to manage brain swelling or neurological symptoms at a dose above 10 mg of prednisone (or equivalent) per day
• People who have had a stroke or mini-stroke (transient ischaemic attack) within 6 months before joining the study
• People with a history of non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition
• People with confirmed cancer spread to the lining of the brain and spinal cord (leptomeningeal disease)
• People with any reason they cannot have an MRI scan, such as having a pacemaker or certain metal implants; an MRI safety questionnaire is required before scanning
• People who have received radiation therapy within 2 weeks before the first vaccine dose, or SRS within 2 weeks before the first vaccine dose, or who have not recovered from radiation-related side effects
• People who have received a live or live-attenuated vaccine (such as the nasal flu spray FluMist) within 30 days before the first study drug dose; injected seasonal flu vaccines are generally permitted, and non-live (killed) vaccines are allowed
• People with a diagnosis of immune deficiency, or who are receiving ongoing steroid therapy above 10 mg of prednisone per day, or any other immune-suppressing treatment within 7 days before the first vaccine dose
• People with another cancer that is currently active or has required treatment within the past 3 years; certain skin cancers or in-situ cancers that have been successfully treated are generally not a reason for exclusion (confirm with trial site)
• Women who are able to become pregnant and have a positive pregnancy test at screening or within 72 hours before leukapheresis
• People with known active cancer involving the membranes surrounding the brain and spinal cord (carcinomatous meningitis)
• People with known psychiatric conditions or substance use disorders that would prevent them from following the study requirements

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