Actively Recruiting
GD2/CD56 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/CD56 bi-specific CAR-T cell therapy in patients with GD2 and/or CD56 positive cancer. Another goal of the study is to learn more about the function of the anti-GD2/CD56 bi-specific CAR-T cells and their persistency in patients.
CONDITIONS
Official Title
GD2/CD56 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 CD56 antigens by immunohistochemistry or flow cytometry
- Body weight of at least 10 kg
- Age between 1 year and 75 years at enrollment
- Life expectancy of at least 8 weeks
- No limit on number of prior treatments; any serious non-blood related side effects from prior therapy must be resolved to mild or less
- No hematopoietic growth factors received within 1 week before mononuclear cell collection
- At least 7 days since last therapy with biologic, targeted, or metronomic non-myelosuppressive agents
- At least 4 weeks since prior monoclonal antibody therapy
- At least 1 week since radiation therapy before study entry
- Karnofsky or Jansky performance score of 60% or higher
- Left ventricular ejection fraction of 40% or greater (55% or greater for Jansky scale)
- Oxygen saturation of 90% or higher on room air
- Liver function tests less than 3 times upper normal limit for ALT and AST; bilirubin and alkaline phosphatase less than 2 times upper normal limit
- Kidney function with serum creatinine less than 3 times upper normal limit
- Bone marrow function with white blood cells at least 1000/ul, neutrophils at least 500/ul, lymphocytes at least 500/ul, and platelets at least 25,000/ul without transfusion
- Patients with bone marrow metastasis eligible if marrow function criteria met and no hematologic toxicity
- Signed informed consent and assent by patients or their parents/legal guardians
You will not qualify if you...
- Severe illness or major organ dysfunction such as significant heart, lung, or liver disease, or blood toxicity greater than grade 2
- Untreatable central nervous system metastasis; patients with treated and stable CNS tumors for at least 6 weeks are eligible
- Prior treatment with other genetically engineered GD2 or CD56-specific CAR T cells
- Active infections including HIV, hepatitis B, or hepatitis C, or uncontrolled infections
- Use of systemic corticosteroids or other immunosuppressive therapies
- Tumors causing airway obstruction
- Inability to follow 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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