Combination immunotherapy for melanoma treatment
Combination of CARTs, CTLs and DC Vaccines Targeting Melanoma
This study is testing a new combination of immune treatments to see if they can help people with advanced melanoma fight their cancer better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | CAR T, radiation, immunotherapy, chimeric antigen receptor |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT06739226 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a combination immunotherapy approach using CAR T cells, cytotoxic T lymphocytes (CTLs), and dendritic cell vaccines modified with GM-CSF and B7-2 against melanoma. The therapy targets specific surface antigens on melanoma cells and aims to enhance the immune response against the tumor. The study will also investigate the persistence and function of these engineered immune cells in patients. By integrating these three immunotherapeutic strategies, the study seeks to improve treatment outcomes for patients with advanced melanoma.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with non-resectable, metastatic, progressive, or recurrent melanoma who have received standard first-line therapy.
Not a fit: Patients with resectable melanoma or those who have not received prior therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with advanced melanoma, potentially improving survival rates.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating melanoma, indicating potential for success in this novel combination strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. 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. 2. Participants must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 3. 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. 4. At least 4 weeks must have elapsed since prior therapy that includes a monoclonal antibody. 5. 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 Criteria: * Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity. * 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. * Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection. * Patients who require systemic corticosteroid or other immunosuppressive therapy. * Evidence of tumor potentially causing airway obstruction. * Inability to comply with protocol requirements. * Insufficient availability of T cells.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-Immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: +86-13671121909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.