Status:
COMPLETED
PD1 Integrated Anti-PSMA CART in Treating Patients With Castrate-Resistant Prostate Cancer
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Bioray Laboratories
Conditions:
Castrate-Resistant Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief Summary
PD1-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
Detailed Description
Clinical trial for the safety and efficacy of Non-viral programmed cell death protein-1(PD1) integrated anti-prostate-specific-membrane-antigen(PSMA) chimeric antigen receptor T(CART) cells in the tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04768608
Start Date
December 23 2021
End Date
May 30 2023
Last Update
July 17 2023
Active Locations (1)
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1
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China