Combination Cell Immunotherapy Tested in Melanoma Patients
Tests combined immune cell therapy against melanoma in adults aged 18 to 75.
Plain-language title generated from the registry record
Registry title: Combination Immunotherapy Targeting Melanoma
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06739226, who can take part
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Trial code
- NCT06739226
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
Combination of CARTs, CTLs and DC Vaccines Targeting Melanoma
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.
Inclusion: Patients with melanoma have received standard first-line therapy and have been diagnosed with non-resectable, metastatic, progressive or recurrent conditions; The expression of melanoma specific antigens is immunohistochemically stained and verified; Body weight greater than or equal to 40 kg; Age: ≥18 year and ≤ 75 years of age at the time of enrollment; Life expectancy: at least 8 weeks; Prior Therapy:; There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must be resolved to grade 2 or less; Participants must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection; At least 7 days must have elapsed since the completion of therapy with any biologic agent, targeted agent, tyrosine kinase inhibitor or metronomic non-myelosuppressive regimen; At least 4 weeks must have elapsed since prior therapy that includes a monoclonal antibody; At least 1 week must has elapsed since any radiation therapy at the time of study entry; Karnofsky/jansky score of 70% or greater; Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent; Pulse Ox greater than or equal to 90% on room air; Liver function: defined as alanine transaminase (ALT) <3x upper limit of normal (ULN), aspartate aminotransferase (AST) <3x ULN; serum bilirubin and alkaline phosphatase <2x ULN; Renal function: Patients must have serum creatinine less than 3 times ULN; Marrow function: White blood cell count ≥1000/ul, Absolute neutrophil count ≥500/ul, Absolute lymphocyte count ≥500/ul, Platelet count ≥25,000/ul (not achieved by transfusion); Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease not evaluable for hematologic toxicity; For all patients enrolled in this study, the patients or their legal guardians must sign an informed consent and assent.
Exclusion: Untreated central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 4 weeks following completion of therapy are eligible; Previous treatment with other genetically engineered CAR T cells; Patients who require systemic corticosteroid or other immunosuppressive therapy; Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity; Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection; Evidence of tumor potentially causing airway obstruction; Inability to comply with protocol requirements; Insufficient availability of T cells.