Actively Recruiting
NG2 and DLL3 CAR-T Cells Targeting Melanoma
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-26
100
Participants Needed
1
Research Sites
226 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 multiple CAR-T cell therapy which targets NG2 and DLL3 surface antigens in patients with relapsed and refractory melanoma.
CONDITIONS
Official Title
NG2 and DLL3 CAR-T Cells Targeting Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with tumors who have received standard first-line therapy and have non-resectable, metastatic, progressive, or recurrent melanoma.
- Tumor must test positive for NG2 and DLL3 antigens by immunohistochemistry or flow cytometry.
- Body weight must be 40 kg or more.
- Age between 18 and 75 years at enrollment.
- Life expectancy of at least 8 weeks.
- No limit on prior treatment regimens; any severe side effects from previous therapies must have improved to mild or less.
- No hematopoietic growth factors within 1 week before mononuclear cell collection.
- At least 7 days since last biologic, targeted agent, tyrosine kinase inhibitor, or non-myelosuppressive regimen.
- At least 4 weeks since last monoclonal antibody therapy.
- At least 1 week since last radiation therapy at study entry.
- Karnofsky/Jansky performance score of 70% or greater.
- 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).
- Renal function with serum creatinine less than 3 times upper limit of normal.
- Bone marrow function meeting specified blood count thresholds (WBC ≥1000/ul, neutrophils ≥500/ul, lymphocytes ≥500/ul, platelets ≥25,000/ul without transfusion).
- Patients with bone marrow metastasis are eligible if marrow function criteria are met.
- Informed consent and assent must be signed by patients or their legal guardians.
You will not qualify if you...
- Severe illness or major organ dysfunction such as significant heart, lung, or liver disease, except for grade 3 blood toxicity.
- Untreated central nervous system (CNS) metastasis; stable CNS involvement for at least 6 weeks after therapy is allowed.
- Prior treatment with other genetically engineered CAR T cells.
- Active infections such as HIV, Hepatitis B, or Hepatitis C, or uncontrolled infection.
- Requirement for systemic corticosteroids or other immunosuppressive therapies.
- Tumor causing airway obstruction.
- Inability to follow 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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