Actively Recruiting
PSMA/CD70 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 study is to assess the feasibility, safety and efficacy of anti-PSMA/CD70 bi-specific CAR-T cell therapy in patients with CD70 and PSMA positive malignancies. Another goal of the study is to learn more about the function of the PSMA/CD70 bi-specific CAR-T cells and their persistency in patients.
CONDITIONS
Official Title
PSMA/CD70 Bi-specific CAR-T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with tumors that have received standard first-line therapy and are non-resectable, metastatic, progressive, or recurrent.
- Positive expression of CD70 or PSMA antigens in tumor tissue confirmed by immunohistochemistry or flow cytometry.
- Body weight of at least 10 kg.
- Age between 1 and 75 years at enrollment.
- Life expectancy of at least 8 weeks.
- No limit on prior treatment regimens; any severe non-hematologic toxicity from previous therapy must be resolved to grade 2 or less.
- No hematopoietic growth factors received within 1 week before mononuclear cell collection.
- At least 7 days since completion of biologic agent, targeted agent, or metronomic non-myelosuppressive therapy.
- At least 4 weeks since prior therapy with monoclonal antibodies.
- At least 1 week since any radiation therapy before study entry.
- Karnofsky/Jansky performance score of 60% or higher.
- Left ventricular ejection fraction of 40% or higher.
- Oxygen saturation of at least 90% on room air.
- Liver function within specified limits: ALT and AST less than 3 times upper normal limit; bilirubin and alkaline phosphatase less than 2 times upper normal limit.
- Renal function with serum creatinine less than 3 times upper normal limit.
- Adequate marrow function: WBC ≥1000/ul, ANC ≥500/ul, ALC ≥500/ul, Platelets ≥25,000/ul without transfusion.
- Patients with known bone marrow metastases are eligible if hematologic function criteria are met and marrow disease causes no hematologic toxicity.
- Informed consent and assent signed by patient or legal guardian.
You will not qualify if you...
- Severe illness or major organ dysfunction including significant cardiac, pulmonary, or hepatic disease, or hematologic toxicity greater than grade 2.
- Untreatable central nervous system metastases; patients with stable CNS tumor involvement for at least 4 weeks after therapy are eligible.
- Previous treatment with other genetically engineered CD70 or PSMA-specific CAR T cells.
- Active HIV, hepatitis B, hepatitis C infection, or uncontrolled infections.
- Requirement for systemic corticosteroid or other immunosuppressive therapy.
- Tumor causing potential airway obstruction.
- Inability to comply with study protocol requirements.
- Insufficient availability of CAR T cells for treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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