PD1 Integrated Anti-PSMA CART in Treating Patients With Castrate-Resistant Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Bioray Laboratories

Criteria

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.