Phase 1 Breast Cancer Trial, Recruiting

Written by an AI model from the 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 have signed a consent form agreeing to take part in the study.
• Women between 18 and 70 years of age.
• People diagnosed with HER2-negative breast cancer that is either locally advanced or has come back and cannot be surgically removed (Stage IIIB–IIIC), or breast cancer that has spread to other parts of the body (Stage IV), and who appear clinically stable in the opinion of the treating doctor.
• People with hormone receptor-positive breast cancer (ER-positive and/or PR-positive) who have already tried at least one hormonal therapy or CDK4/6 inhibitor treatment, or who the treating doctor considers suitable for chemotherapy — prior chemotherapy lines are not limited.
• People with triple-negative breast cancer (a subtype with no hormone or HER2 receptors) who may have had any number of prior treatments.
• People who have never previously received a type of treatment called adoptive cell therapy (a treatment using immune cells grown outside the body).
• People the treating doctor considers suitable for treatment with a drug called camrelizumab combined with one other anti-cancer drug (chosen from chemotherapy, an antibody-drug conjugate, or a PARP inhibitor).
• People who have lymph nodes near the tumour that can be accessed through surgery to allow immune cells to be grown for the treatment.
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People who are able to provide a recent tumour tissue sample (biopsy) for laboratory testing, unless it is not safe or not possible to do so.
• People with a general health and activity level rated as 0 or 1 on a standard scale used in cancer trials (meaning fully active or restricted only in physically demanding activity) (confirm with trial site).
• People with a life expectancy of at least 4 months.
• People whose blood counts, liver, kidney, heart, lung, and clotting function all meet specific minimum levels as measured by blood and other tests (confirm specific values with trial site).
• Women who could become pregnant must be willing to use an effective form of contraception throughout the study and for at least one year after the last treatment dose, and must have a negative pregnancy blood test within 7 days before receiving the cell infusion.
• People who have waited a required period of time after finishing previous cancer treatments before joining (ranging from 1 week for hormonal therapy up to 4 weeks for certain other treatments), and whose side effects from prior treatment have largely resolved.

Who may not be able to join:

• People whose cancer is judged by the treating doctor to be progressing rapidly.
• People with active cancer that has spread to the brain or the lining around the brain, unless it was previously treated and has been stable on at least two brain scans taken at least 4 weeks apart, or does not require medication or steroids to manage.
• People with pressure on the spinal cord that has not been relieved by surgery or radiotherapy.
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen (exceptions may apply if a drainage tube is already in place).
• People with cancer pain that is not adequately controlled.
• People who have had another cancer in the last 5 years that is still active or requires treatment (some skin cancers and certain thyroid or cervical cancers may be exceptions — confirm with trial site).
• People with significant heart conditions, including severe heart failure, unstable chest pain, a heart attack in the past 3 months, or certain heart rhythm problems requiring treatment.
• People with active or clinically significant lung inflammation or other serious lung conditions affecting breathing.
• People with an active infection requiring antibiotic or other systemic treatment, or an unexplained fever above 38.5°C not caused by cancer.
• People who have had a blood clot in an artery or vein (such as a stroke, deep vein thrombosis, or pulmonary embolism) in the past 5 months.
• People currently taking part in another clinical trial using an experimental treatment or device, or who have done so within the past 4 weeks (those in a follow-up phase of a prior trial may be considered if at least 4 weeks have passed since the last dose).
• People with a known psychiatric condition, or alcohol or substance use disorder.
• People who are pregnant or breastfeeding.
• People with an active autoimmune disease, or a history of autoimmune disease that required ongoing treatment with significant doses of steroids or similar medications (hormone replacement therapies such as thyroid or insulin are generally permitted).
• People with a known immune deficiency condition, including HIV.
• People who have had active tuberculosis within the past year, or a history of tuberculosis more than a year ago that was not properly treated.
• People with active hepatitis B or hepatitis C (some people who carry these viruses but have normal virus levels in their blood may be considered, provided they receive antiviral therapy and regular monitoring during the trial — confirm with trial site).
• People who have received a live vaccine within 4 weeks before joining, or who plan to receive one during the trial.
• People who have previously had a bone marrow or organ transplant from another person.
• People with a known allergy or serious reaction to any of the drugs or substances used in this study, including the cell therapy itself, chemotherapy drugs (cyclophosphamide, fludarabine), interleukin-2, camrelizumab, or other components such as DMSO, human serum albumin, dextran-40, or certain antibiotics.
• People who have contraindications to interleukin-2, including uncontrolled epilepsy or active bleeding in the digestive tract.
• People with a history of moderate or severe nerve damage (Grade 2 or higher neuropathy).
• People currently taking medications that are not permitted to be used alongside the study treatments, unless those medications were stopped at least 7 days before joining.
• People with any other condition, treatment history, or test result that the treating doctor believes could affect the study results or make participation unsuitable.

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