Prostate cancer
Conditions
Interventions
Experimental group:PSMA-CAR-T cell transfusion
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years. 2. Patients who have failed treatment with at least one docetaxel-containing chemotherapy and one standard new endocrine drug. 3. Met the diagnosis of mCRPC, defined as a depot level of testosterone =2ng/ml; soft tissue progression as evaluated by RECIST criteria, or >=2 new lesions on bone scan. 4. Fresh tissue IHC analysis demonstrating = 10% tumor cells expressing PSMA; if no lesions are desirable for biopsy, a positive PSMA test or positive 68Ga-PSMA PET/CT of the original tissue specimen is required. 5. Imaging evidence of bone metastatic disease and/or measurable non-bone metastatic disease (lymph node or visceral). 6. Expected survival of more than 3 months. 7. ECOG physical fitness score of 0-2. 8. Adequate blood reserve, defined as HB >= 90 g/L, ANC >= 1.5 K/UL, PLT >= 70 K/UL, and not transfusion dependent. 9. Good organ function, defined as: blood creatinine = 60 cc/min, blood total bilirubin < 1.5 x ULN, and blood ALT/AST < 2 x ULN. 10. Agree to use effective contraception during treatment and for 1 year thereafter. 11. Able to fully understand the purpose and risks of the treatment and willing to sign the informed consent form related to the treatment.
Exclusion criteria
Exclusion criteria: 1) Prior use of CAR-T cell therapy against prostate cancer. 2) History of non-prostate primary malignancy within the past 5 years. 3) Elevated PSA without imaging evidence of metastatic disease, i.e., biochemical recurrence. 4) Concomitant other diseases requiring systemic treatment with immunosuppressive drugs or hormones. 5) Clinical history, physical examination, or MRI suggestive of symptomatic vertebral metastases impacting spinal cord function. 6) Class III/IV cardiovascular disease according to the New York Heart Association classification. 7) History of deep vein thrombosis or pulmonary embolism within six months of enrollment. 8) Active bleeding disorders or coagulation disorders. 9) Uncontrollable active infection. 10) Human immunodeficiency virus (HIV) positivity. 11) Active hepatitis B or C infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of remission;Progression-free survival;Overall survival;Prostate-specific antigen;Free PSA; | — |
Countries
China
Contacts
Public ContactJiyan Liu
West China Hospital of Sichuan University
Outcome results
None listed