A Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor T-cell (CART) in the Treatment of Solid Tumors

This is a single-arm, investigator-initiated exploratory study.The study is designed to evaluate the safety and the tolerability of HER2-E-CART cells for the treatment of patients with HER2-positive, refractory advanced solid tumors in three dose groups: low, medium and high.

Inclusion Criteria:Voluntarily signed an informed consent form and were able to complete the study procedures and follow-up examinations and treatmentAge ≥ 18 years and ≤ 70 years, regardless of genderWeight > 40 kgEastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1Patients with refractory advanced solid tumors who have failed or are intolerant of existing standard regimens or whose patients have refused standard regimensThe presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors 1.1 criteriaWith good organ functionPositive HER2 cell membrane expressionWomen of childbearing potential must have a pregnancy test with negative results within 7 days prior to initiation of treatmentExclusion Criteria:Any systemic antitumor therapy within 2 weeks prior to the single blood collectionHistory of organ transplantationPregnant or lactating womenUncontrolled infectious disease, such as baseline Hepatitis B Virus DNA ≥ 1000 IU/ml, anti-HIV positive, Hepatitis C Virus-RNA positiveOther clinically significant active infectionsOther active malignancies within the previous 5 years, such as basal or squamous skin cancer, superficial bladder cancer, or in situ breast cancer that has been completely cured and does not require follow-up treatment subjects are not includedPatients with severe autoimmune or immunodeficiency diseases, such as subjects with a confirmed diagnosis of a severe autoimmune disease requiring systemic immunosuppressive (steroid) therapy for a prolonged period of time (more than 2 months) or with immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis), etcSubjects with known severe allergic reactions to pretreatment drugs such as injectable cyclophosphamide, injectable paclitaxel (albumin-bound), or CAR-T cell preparations including adjuvants, dimethylsulfoxideAny unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification ≥ Class III congestive heart failure, severe arrhythmias poorly controlled by medications, liver, kidney or metabolic disease, and hypertension uncontrolled by standard therapy 10Those with active bleeding, thrombotic disorders requiring treatmentPatients with pericardial, thoracic, or abdominal effusions requiring clinical management or interventionThe presence of known or suspected brain metastases, including central nervous system and spinal cord compressions or meningeal metastasesSubjects undergoing treatment with systemic steroids or steroid inhalersSubjects with any psychiatric disorder, including dementia, altered mental status, that may interfere with informed consent and understanding of relevant questionnairesHaving participated in another clinical trial within the previous 30 daysHave received a live or attenuated vaccine within 4 weeks prior to pretreatmentThose who have been judged by the investigator to have a serious uncontrollable disease or have other conditions that may interfere with receiving treatment in this study and are considered unsuitable