metastatic castration-resistant prostate cancer
Conditions
Interventions
Group 1:5 x 10^6 DC cells, once every two weeks, a total of three times
Group 2:10 x 10^6 DC cells, once every two weeks, a total of three times
Group 3:15 x 10^6 DC cells, once every two weeks, a total of three times
Group 4:One dose is preferred from dose groups 1-3, once every 2 weeks, a total of 3 times
then once every 4 weeks, until disease progression or intolerance or withdrawal of informed consent.
Sponsors
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Prostate adenocarcinoma diagnosed by histopathology or cytology, except for neuroendocrine or small cell features in the first diagnosis; 2. Patients with metastatic castration-resistant prostate cancer (mCRPC) who failed new endocrine therapy and docetaxel chemotherapy, and the first dose is more than 4 weeks from the end of the last anti-tumor therapy. (Failure of previous new endocrine therapy and docetaxel chemotherapy refers to: disease progression or intolerability after previous new endocrine therapy and docetaxel chemotherapy. New endocrine therapy refers to new androgen pathway blocking drug therapy, including Enza Lutamide/abiraterone/alpalutamide/dalutamide (any one or more).Disease progression is defined as: serum testosterone maintains castrated levels ( 1 ng/mL; (2) Imaging progress: Two or more new lesions or enlargement of soft tissue lesions meeting the solid tumor response evaluation criteria are found on bone scan. Intolerable is defined as: there have been adverse reactions of grade 2 or above in the previous treatment, or the patient clearly refuses to receive chemotherapy, or the investigator judges that it is not suitable for chemotherapy (including but not limited to age >= 80 years old); 3. Did not participate in other clinical research within 30 days before screening; if participating in other clinical research within 3 months before screening, it needs to be confirmed by the investigator that the test drug will not affect the safety and effectiveness of the follow-up test drug; 4. Age >= 18 years old when signing the ICF, male, weight >= 50kg; 5. ECOG score is 0-2; 6. Subjects who voluntarily sign a written informed consent form before the start of any research procedure have good compliance and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. mCRPC patients who have a clear BRCA gene mutation in the past and plan to receive olaparib treatment; 2. Plan to try (re)use docetaxel or other chemotherapy drugs; 3. mCRPC patients who plan to receive radium-223 treatment; 4. mCRPC patients who plan to participate in other clinical research; 5. Pathological long bone fracture (cortical erosion > 50% on imaging) or spinal cord compression; 6. There is a history of other malignant tumors in the past 5 years (excluding those that have been clinically cured within 5 years of diagnosis), except for squamous cell carcinoma or skin basal cell carcinoma; 7. Immunosuppressants (such as cyclosporine CsA, tacrolimus, rapamycin and azathioprine, etc.) were used within one month before screening; 8. Patients with multiple oral, intramuscular or intravenous corticosteroid injections within 28 days before enrollment; however, short-term use of corticosteroids is allowed to prevent reactions to intravenous contrast agents used in imaging examinations; inhalation of corticosteroids for respiratory treatment is allowed Insufficiency (such as chronic obstructive pulmonary disease), or topical steroids; 9. Infectious disease screening positive (HBV/HCV/HIV/syphilis/COVID-19); Infectious disease screening positive includes: positive hepatitis B surface antigen and HBV DNA >= ULN (only in patients with positive hepatitis B surface antigen); positive hepatitis C virus (HCV) antibody; positive nucleic acid test for novel coronavirus (COVID-19); human Immunodeficiency virus (HIV) antibody positive; Treponema pallidum specific antibody (TP-Ab) positive; 10. Myocardial infarction, unstable angina pectoris, cardiac surgery or interventional therapy occurred within 6 months before enrollment; previous or current congestive heart failure, atrial fibrillation or other poorly controlled arrhythmias. 11. Cerebrovascular events (including hemorrhagic, ischemic, and transient ischemic attacks), brain surgery, and unexplained loss of consciousness occurred within 6 months before enrollment; 12. There is malignant pleural effusion or malignant ascites; 13. Those who have a history of severe allergies or allergies; patients who have a clear history of allergies to the ingredients of this product; 14. Abnormal blood routine: white blood cell count (WBC) = upper limit of normal (ULN), international normalized ratio (INR) >= ULN, thrombin time (TT) >= ULN; 16. Patients with obviously abnormal liver and kidney function: total bilirubin (TBIL) > 1.5 ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 ULN; serum creatinine (SCr) > 1.5 ULN; 17. History of splenectomy; 18. Suffering from primary or secondary immunodeficiency diseases; 19. Patients with uncontrollable epileptic seizures, central nervous system disorders or mental illness loss of cognitive ability; 20. Patients have a history of chronic alcohol or drug abuse 6 months before screening; 21. Unstable systemic diseases, such as active infection, liver cirrhosis, chronic renal failure, severe chronic lung diseases, etc.; 22. Clinically severe pericardial effusion; 23. Those who are not suitable for leukocyte collection; 24. Those who are considered by the researchers to be inappropriate to participate in the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ECOG score;physical examination;vital signs;laboratory tests;Adverse events;serious adverse events ; | — |
Countries
China
Contacts
Public ContactWang Linhui
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Outcome results
None listed