Castrate-Resistant Prostate Cancer Clinical Trial
Official title:
Clinical Trial for the Safety and Efficacy of Non-viral PD1 Integrated Anti-PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castrate-Resistant Prostate Cancer
Verified date | July 2023 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
Status | Completed |
Enrollment | 3 |
Est. completion date | May 30, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Fully understand and voluntarily sign informed consent. - Aged 18 to 75 years old. - Expected survival > 6 months. - CRPC patients:Serum testosterone reached castration level (<50ng/dl or<1.7nmol/L) and: prostate specific antigen (PSA) increased more than 50% at intervals of one week or three consecutive times, with PSA>2 ng/ml; 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 imaging showed local recurrence or new metastasis). - Immunohistochemical staining of repetitive biopsy tissues showed the expression of PSMA in tumor cells was more than 50%. - Eastern Cooperative Oncology Group (ECOG) score =2. - Virological examination was negative. - Hematological indexes: hemoglobin > 100 g/L, platelet count > 100×10^9/L, absolute neutrophil count > 1.5×10^9/L. Exclusion Criteria: - Prior treatment with any CART therapy targeting any target. - Prior treatment with any PSMA targeting therapy. - Need steroid therapy, except physiological replacement therapy. - Prior treatment with any immunotherapy, including tumor vaccine therapy, radium-223, checkpoint inhibitors and others. - Subjects with severe mental disorders. - Subjects with other malignant tumors. - 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 (left ventricular ejection fraction< 55%) was decreased by echocardiography or multiple gated acquisition scan (within 8 weeks before peripheral blood mononuclear cell (PBMC) collection), and abnormal interventricular septal thickness and atrioventricular size associated with myocardial amyloidosis. - Patients with ongoing or active infection. - Organ function: a, Alanine aminotransferase or Aspartate aminotransferase >2.5*Upper limit of normal (ULN); Creatine kinase>1.5*ULN; Creatine kinase isoenzyme >1.5*ULN; Troponin T >1.5*ULN; b, Total bilirubin >1.5*ULN; c, 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University | Bioray Laboratories |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events | All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set. | 28 days | |
Secondary | Prostate specific antigen (PSA) response rate | proportion of patients with =50% PSA decline from baseline at any time point after therapy and maintained for =4weeks | 180 days | |
Secondary | Radiographic response rate by RECIST 1.1 & PCWG3 | Proportion of patients with a best response of either complete response or partial response, assessed using Prostate Cancer Working group3(PCWG3) response criteria & Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 | 180 days | |
Secondary | Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry | Number of persistent CART cells detected by Quantitative Real-time Polymerase Chain Reaction or flow cytometry | 180 days |
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