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Recruiting Phase 1

CART-PSMA Cells for Advanced Prostate Cancer

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About this study

This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.

Condition
Prostate Cancer
Tested
CART-PSMA cells
Sponsor
Nova Therapeutics LLC

Who can join

Age
35 to 85 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 35 years
  • Maximum age: 85 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • All participants must have the ability to understand and the willingness to sign a written informed consent.
  • Histologic confirmation of prostate cancer.
  • Tumor expressing PSMA as demonstrated by immunohistochemistry analysis or other methods.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  • Under general air conditions, blood oxygen saturation \>90%.
  • Adequate liver function, specifically alanine aminotransferase (ALT) \< 3 times of upper limit of normal (ULN), aspartate transferase (AST)\< 3 times of ULN, serum bilirubin and alkaline phosphatase \< 2 times of ULN.
  • Adequate renal function, specifically serum creatinine \< 2.0 mg/dl.
  • Adequate cardiac function, specifically left ventricular ejection fraction (LVEF)≥50%.
  • Hemoglobin concentration ≥80g/L.
  • The side effects brought by the latest treatment should be recovered, and the latest chemotherapy should be at least 7 days before; At least three t½ have passed since the latest immunotherapy.

Exclusion 10

  • Patients with other malignant tumors or major diseases.
  • Patients who are already undergoing other clinical drug trials or other gene therapy or cell therapy.
  • Patients with uncontrolled active infection.
  • Patients with active hepatitis B or hepatitis C infection.
  • Patients with human immunodeficiency virus (HIV) infection.
  • Patients who are being treated with immunosuppressive agents or systemic steroids (other than inhalation therapy).
  • Patients with various types of serious heart disease or a history of severe cerebrovascular disease.
  • Patients with congenital immune deficiency diseases or bone marrow deficiency diseases.
  • Patients with active autoimmune disease, including connective tissue disease, uveitis, inflammatory bowel disease, or multiple sclerosis; or a history of severe (as judged by the physician-investigator) autoimmune disease requiring prolonged immunosuppressive therapy.
  • Patients with active medical condition that, in the opinion of the physician-investigator, would substantially increase the risk of uncontrollable CRS (cytokine release syndrome) or CAR Neurotoxicity.

Where

1 site, 1 recruiting

Chinese PLA General Hospital

Beijing, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.