Actively Recruiting
GD2/PSMA Bi-specific CAR-T Cell Therapy
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2022-06-29
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2/PSMA bi-specific CAR-T cells and their persistency in patients.
CONDITIONS
Official Title
GD2/PSMA Bi-specific CAR-T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with tumors that are non-resectable, metastatic, progressive, or recurrent after standard first-line therapy
- Tumor tissue must test positive for GD2 or PSMA antigen by immunohistochemistry or flow cytometry
- Body weight must be 10 kg or more
- Age between 1 year and 75 years at enrollment
- Life expectancy of at least 8 weeks
- Any prior treatment is allowed if grade 3 or 4 non-hematologic toxicity has resolved to grade 2 or less
- No hematopoietic growth factors received within 1 week before mononuclear cell collection
- At least 7 days since therapy with biologic, selected targeted, or metronomic non-myelosuppressive agents
- At least 4 weeks since prior monoclonal antibody therapy
- At least 1 week since any radiation therapy
- Karnofsky/Jansky performance score of 60% or greater
- Cardiac left ventricular ejection fraction of 40% or higher
- Pulse oxygen saturation of 90% or higher on room air
- Liver function tests within specified limits: ALT and AST less than 3 times upper limit of normal, bilirubin and alkaline phosphatase less than 2 times upper limit of normal
- Renal function with serum creatinine less than 3 times upper limit of normal
- Adequate marrow function with WBC count ≥1000/µl, ANC ≥500/µl, ALC ≥500/µl, and platelet count ≥25,000/µl (not transfusion dependent)
- Patients with bone marrow metastasis are eligible if marrow function criteria are met and there is no hematologic toxicity from marrow disease
- Informed consent and assent signed by patient or guardians
You will not qualify if you...
- Severe illness or major organ dysfunction including significant cardiac, pulmonary, or hepatic disease, or greater than grade 2 hematologic toxicity
- Untreatable central nervous system metastasis (patients with treated and stable CNS tumors for at least 6 weeks are eligible)
- Previous treatment with genetically engineered GD2 or PSMA-specific CAR T cells or antibody therapy
- Active HIV, Hepatitis B, or Hepatitis C infection, or uncontrolled infection
- Requirement for systemic corticosteroids or other immunosuppressive therapy
- Tumor causing potential airway obstruction
- Inability to comply with study protocol requirements
- Insufficient availability of CAR T cells
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Lung-Ji Chang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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