castration resistant prostate cancer
Conditions
Interventions
1:PSCA-CAR-T infusion at dose of 5×10*7
2:PSCA-CAR-T infusion at dose of 1×10*8
3:PSCA-CAR-T infusion at dose of 5×10*8
4:PSCA-CAR-T infusion at dose of 1×10*9
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed as CRPC,difination: (1)Castrate serum testosterone 2 ng/mL or(3) Radiological progression: The appearance of new lesions: either two or more new bone lesions on bone scan or a soft tissue lesion; 2. KPS >6; 3. Adequate organ function, as defined by: (1) Serum creatinine = 1.5 mg/dl or creatinine clearance = 60 cc/min; (2) Serum total bilirubin 9 g/dl; (5) PLT > 100 k/ul; (6) ANC > 1.5 k/ul; 4. Normal cardiac function was (ejection fraction = 40%). 5. Provides written informed consent, voluntary participation; 6. Patients aged 18 to 85 years.
Exclusion criteria
Exclusion criteria: 1. Allergic to cytokines or history of severe drug allergies 2. Patients with ongoing or active infection. 3. Acute or chronic graft versus host reaction 4. Multiple organ failure 5. Subjects who require the chronic use of systemic corticosteroid therapy 6. History of active autoimmune disease requiring immunosuppressive therapy 7. Active hepatitis B, hepatitis C or HIV infection. 8. With other malignant tumors coexist, or other serious diseases (autoimmune diseases, immunodeficiency, etc.) 9. Subjects with physical or mental illnesses that the researchers believe pose a risk, interfere with the results of the study, or interfere with the participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Tumor load; | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic Kinetics of PSCA-CAR-T cells; | — |
Countries
China
Contacts
Public ContactCai Jianhui
Hebei General Hospital
Outcome results
None listed