Actively Recruiting
Combination Immunotherapy Targeting Melanoma
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-09
30
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 combination immunotherapy based on CAR T cells, cytotoxic T lymphocytes (CTLs), and dendritic cell (DC) vaccines modified with GM-CSF and B7-2 (CD86) against melanoma, which targets CAR T specific surface antigens such as GD2, CTL specific antigens such as MAGE-A4, gp100 and a pool of melanoma specific antigens presented by the DCs. Another goal of the study is to learn more about the function and persistence of the CAR T cells and antigen-specific immune effectors in patients.
CONDITIONS
Official Title
Combination Immunotherapy Targeting Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with melanoma who have received standard first-line therapy and have non-resectable, metastatic, progressive, or recurrent disease.
- Melanoma-specific antigens confirmed by immunohistochemical staining.
- Body weight of 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 prior grade 3 or 4 non-hematologic toxicity must be resolved to grade 2 or less.
- No hematopoietic growth factors received for at least 1 week before mononuclear cell collection.
- At least 7 days since last therapy with biologic agents, targeted agents, tyrosine kinase inhibitors, or metronomic non-myelosuppressive regimens.
- At least 4 weeks since prior monoclonal antibody therapy.
- At least 1 week since any radiation therapy.
- Karnofsky/Jansky performance score of 70% or greater.
- Left ventricular ejection fraction of 40/55% or higher.
- Pulse oximetry of 90% or higher on room air.
- Liver function with 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.
- Marrow function with white blood cell count ≥1000/µl, absolute neutrophil count ≥500/µl, absolute lymphocyte count ≥500/µl, platelet count ≥25,000/µl (not from transfusion).
- Patients with bone marrow metastases are eligible if marrow function criteria are met and marrow disease is not evaluable for hematologic toxicity.
- Signed informed consent and assent obtained.
You will not qualify if you...
- Severe illness or major organ dysfunction such as significant cardiac, pulmonary, or hepatic disease, except grade 3 hematologic toxicity.
- Untreated central nervous system metastasis; patients with treated and stable CNS tumor for at least 4 weeks are eligible.
- Previous treatment with other genetically engineered CAR T cells.
- Active HIV, Hepatitis B, or Hepatitis C infection, 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 T cells for therapy.
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here