A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART in Treating Patients With Refractory Castrate-Resistant Prostate Cancer (CRPC)
Condition: Castrate-Resistant Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04053062
Sponsor: Shanghai Bioray Laboratory Inc.
Phase: Phase 1/Phase 2
- Age: minimum 18 Years maximum 75 Years
- Gender: Male
- Fully understand and voluntarily sign informed consent.
- Male, aged 18 to 75 years old.
- Expected survival > 6 months.
- CRPC patients: Prostate cancer is still progressing after continuous androgen deprivation therapy. Including, castrate levels of serum testosterone (<50ng/dl or <1.7nmol/L); or prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, and PSA>1 ug/L; or imaging scans revealed two or more new lesions or enlargement of soft tissue lesions that met the criteria for evaluating solid tumor response.
- CRPC patients received abiraterone or chemotherapy for 3 months or more, and were ineffective or progressive (PSA continued to rise for 3 months, or bone scan/whole-body MRI/PET-CT showed local recurrence or new metastasis).
- Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%.
- ECOG score <2.
- Hgb > 10 g/dl.
- PLT > 100×109/L.
- ANC > 1.5×109/L. Exclusion Criteria: Subjects who meet any of the following
- Subjects who meet any of the following exclusion criteria will be excluded
- Prior treatment with any immunotherapy, including CART therapy, tumor vaccine therapy, radium-223, checkpoint inhibitors.
- Prior treatment with any PSMA targeting therapy.
- Subjects with severe mental disorders.
- Subjects with severe cardiovascular diseases: a, New York Heart Association (NYHA) stage III or IV congestive heart failure; b, history of myocardial infarction or coronary artery bypass grafting (CABG) within 6 months; c, clinical significance of ventricular arrhythmia, or history of unexplained syncope, non-vasovagal or dehydration; d, history of severe non-ischemic cardiomyopathy; e, the left ventricular ejection fraction (LVEF < 55%) was decreased by echocardiography or MUGA scan (within 8 weeks before PBMC collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis.
- Patients with ongoing or active infection.
- Aspartate aminotransferase or Alanine aminotransferase ＞2.5*ULN；CK＞*ULN； CK-MB＞*ULN；TnT＞1.5*ULN.
- Total bilirubin ＞ 1.5*ULN.
- Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment.
- History of participation in other clinical studies within 3 months or treatment with any gene therapy product.
- Intolerant or allergic to cyclophosphamide or fludarabine.
- Subjects not appropriate to participate in this clinical study judged by investigators.
View trial on ClinicalTrials.gov