Actively Recruiting
Study on GD2 Positive Solid Tumors by 4SCAR-GD2
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-08
100
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. The investigators are attempt to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognition of GD2, a surface protein expressed at high levels on many types of tumors but not on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.
CONDITIONS
Official Title
Study on GD2 Positive Solid Tumors by 4SCAR-GD2
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 must test positive for GD2 antigen by immunohistochemistry or flow cytometry
- Body weight of 10 kg or more
- Age between 1 year and 65 years at enrollment
- Life expectancy of at least 8 weeks
- No limit on number of prior treatments; prior severe side effects must have improved to grade 2 or less
- No hematopoietic growth factors within 1 week before cell collection
- At least 7 days since biologic, targeted, tyrosine kinase inhibitor, or metronomic nonmyelosuppressive therapy
- At least 4 weeks since prior monoclonal antibody therapy
- At least 1 week since any radiation therapy
- Karnofsky or Lansky score of 60% or higher
- Left ventricular ejection fraction of 40% or higher
- Pulse oximetry of 90% or higher on room air
- Liver enzymes (ALT and AST) less than 3 times upper limit of normal; bilirubin and alkaline phosphatase less than 2 times upper limit
- Serum creatinine less than 3 times upper limit of normal
- Blood counts: WBC ≥1000/µL, absolute neutrophils ≥500/µL, absolute lymphocytes ≥500/µL, platelets ≥25,000/µL without transfusion
- Patients with bone marrow metastasis eligible if marrow function criteria met
- Informed consent and assent signed by patients or guardians
You will not qualify if you...
- Severe illness or major organ dysfunction, except grade 3 blood toxicity
- Untreated central nervous system metastases; patients with treated and stable CNS tumors for at least 6 weeks are eligible
- Previous treatment with other genetically engineered GD2-CAR T cells
- Active HIV, hepatitis B or C infection, or uncontrolled infection
- Need for systemic corticosteroids or other immunosuppressive therapy
- Tumor causing airway obstruction
- Inability to follow study 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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