Combination of CARTs, CTLs and DC Vaccines Targeting Melanoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shenzhen Geno-Immune Medical Institute
RECRUITING
Shenzhen
Contact Information
Primary
Lung-Ji Chang, PhD
c@szgimi.org
+86-13671121909
Time Frame
Start Date: 2025-08-31
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 30
Treatments
Experimental: CAR T/CTL/DCvac cells to treat melanoma
Antigen-specific CAR T, CTL and DCvac to treat melanoma.
Related Therapeutic Areas
Sponsors
Leads: Shenzhen Geno-Immune Medical Institute

This content was sourced from clinicaltrials.gov

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