MUC1 positive advanced breast cancer
Conditions
Interventions
Case series:AJMUC1
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 Years; 2. Pathologically diagnosed as recurrent/metastatic breast cancer (excluding intracranial metastasis), who have received at least one standard treatment regimen, whose condition is stable or progressive, and refuse to receive chemotherapy again; 3. Abnormal glycosylated MUC1 expression confirmed by immunohistochemistry in tumor tissues or puncture tissues within 12 months. 4. Expected survival time>= 4 months; 5. Eastern Cooperative Oncology Group (ECOG) score 1.5*10^9/L; (2) Platelet (PLT)>75*10^9/L; (3) Hemoglobin (HGB) > 9g/dl; (4) Total Bilirubin (TIBC) =60ml/min; (6) Alanine Aminotransferase (ALT) or Aspartic Transaminase (AST) < 2.5*upper normal limits(ULN) (subjects with liver involvement < 5 *ULN); (7) Coagulation function: INR<=1.5 ULN, PTT<1.2 ULN (except for tumor related anticoagulation therapy).
Exclusion criteria
Exclusion criteria: 1. Immunosuppressive drugs or hormones were used within 1 week before enrollment. 2. Patients with moderate symptoms of symptomatic relief by catheter drainage and those with moderate or above pleural and abdominal fluid; 3. Human immunodeficiency virus (HIV) positive; 4. Active hepatitis B or C infection; 5. Pregnant or lactating women; 6. Previous or concurrent history of other malignancies, excluding patients with curable basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; 7. Central metastasis; 8. Serious, uncontrolled concomitant illness that may affect protocol compliance or interfere with interpretation of results, or any serious medical condition that may affect the safety of the subject (e.g., uncontrolled heart disease, hypertension, activity or uncontrollable infection, etc.); 9. Active autoimmune diseases (including but not limited to systemic lupus erythematosus, sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.); 10. History of organ transplantation; 11. Subjects who had received the last dose of treatment less than 4 weeks before enrollment, or who also participated in other relevant clinical studies; 12. History of gene therapy; 13. Live vaccine was administered within 4 weeks before the study; 14. A history of myocardial infarction and serious arrhythmia within half a year; Uncontrolled hypertension, coronary heart disease, stroke, cirrhosis, nephritis or other serious complications; 15. History of psychotropic substance abuse and unable to quit or history of mental disorder; 16. Hypersensitivity, allergic to human serum albumin; 17. Hemorrhage and thrombosis tendencies: the first 3 months there have been significant clinical significance of bleeding symptoms or have a definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, coagulant function abnormality (PT >16 s, APTT, TT >43 s 21 s, FIB < 2 g/L), there is tendency of inherited or acquired bleeding and thrombosis (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, the splenic function, etc.), were treated with thrombolysis and anticoagulation, six months before moving/enous thromboembolism events, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 18. Other severe, acute or chronic medical or psychiatric conditions that may increase the risk of participating in the study or may interfere with the interpretation of the study results, according to the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity(DLT);Ratio and severity of toxicity and adverse events;The number of peripheral blood CAR copies in 3 months after AJMUC1 infusion (2h/D1/ 3/7/14/21 +/-1/28+/-2/56+/-3/84+/-3); | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimal disease control rate within 3 months (DCR=CR+PR+SD); | — |
Countries
China
Contacts
Public ContactErwei Song, Herui Yao
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed