Actively Recruiting
GD2/CD70 Bi-specific CAR-T Cell Therapy
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2022-06-30
30
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 GD2/CD70 bi-specific CAR-T cell therapy in patients with GD2 and/or CD70 positive tumor. Another goal of the study is to learn more about the function of the GD2/CD70 bi-specific CAR-T cells and their persistency in patients.
CONDITIONS
Official Title
GD2/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.
- Tumor tissue must test positive for GD2 or CD70 antigens by immunohistochemistry or flow cytometry.
- Body weight must be 10 kg or greater.
- Age between 1 and 75 years at enrollment.
- Life expectancy of at least 8 weeks.
- No limit on prior treatment regimens; any grade 3 or 4 non-hematologic toxicity from previous therapy must have 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 agents, selected targeted agents, or metronomic non-myelosuppressive regimens.
- At least 4 weeks since prior monoclonal antibody therapy.
- At least 1 week since any radiation therapy.
- Karnofsky or Jansky score of 60% or higher.
- Left ventricular ejection fraction of 40% or greater (adults) or 55% or greater (children).
- Pulse oximetry of 90% or higher on room air.
- Liver function: 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: serum creatinine less than 3 times upper limit of normal.
- Bone marrow function: WBC count ≥1000/µL, ANC ≥500/µL, ALC ≥500/µL, platelet count ≥25,000/µL (not due to transfusion).
- Patients with known bone marrow metastatic disease may participate if marrow function criteria are met and no hematologic toxicity is present.
- Informed consent and assent signed by patient or legal guardian.
You will not qualify if you...
- Severe illness such as significant cardiac, pulmonary, or hepatic diseases, major organ dysfunction, or greater than grade 2 hematologic toxicity.
- Untreatable central nervous system metastasis; patients with stable CNS tumor involvement for at least 6 weeks after treatment are eligible.
- Previous treatment with genetically engineered GD2 or CD70-specific CAR T cells.
- Active infections including HIV, hepatitis B, hepatitis C, 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
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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