Actively Recruiting
CART-PSMA Cells for Advanced Prostate Cancer
Led by Nova Therapeutics LLC · Updated on 2024-11-15
20
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
N
Nova Therapeutics LLC
Lead Sponsor
C
Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CART-PSMA Cells for Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent
- Histologic confirmation of prostate cancer
- Tumor expressing PSMA confirmed by immunohistochemistry or other methods
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Blood oxygen saturation above 90% under normal air conditions
- Adequate liver function: ALT and AST less than 3 times upper limit of normal, bilirubin and alkaline phosphatase less than 2 times upper limit
- Adequate kidney function: serum creatinine less than 2.0 mg/dl
- Adequate heart function: left ventricular ejection fraction 50% or higher
- Hemoglobin concentration 80g/L or higher
- Side effects from previous treatment resolved; at least 7 days since last chemotherapy; at least 3.5 weeks since last immunotherapy
You will not qualify if you...
- Presence of other malignant tumors or major diseases
- Currently enrolled in other clinical drug trials or gene/cell therapy
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- HIV infection
- Treatment with immunosuppressive agents or systemic steroids (except inhalation therapy)
- Serious heart disease or history of severe cerebrovascular disease
- Congenital immune deficiency or bone marrow deficiency diseases
- Active autoimmune disease or history of severe autoimmune disease requiring long immunosuppressive therapy
- Active medical conditions increasing risk of uncontrollable cytokine release syndrome or CAR neurotoxicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jay Zhang, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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