Combination Immunotherapy Targeting Melanoma

NCT06739226 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-24004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

melanoma; CART; chimeric antigen receptor; CTL; DC; vaccine; GD2

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  The toxicity profile of CAR T, CTL or DCvac is determined by Common Toxicity Criteria for Adverse Effects version 4.0

  1 year

Secondary Outcomes (7)

• Anti-tumor effects

  1 year

• The expansion and persistency of antigen-specific CAR T cells

  1 year

• Immune responses after CAR T and CTL infusions and DCvac injections

  1 year

• Immune responses after CAR T and CTL infusions and DCvac injections

  1 year

• Immune responses after CAR T and CTL infusions and DCvac injections

  1 year

Study Arms (1)

CAR T/CTL/DCvac cells to treat melanoma

EXPERIMENTAL

Antigen-specific CAR T, CTL and DCvac to treat melanoma.

Biological: Antigen-specific CAR T, CTL and DCvac to treat melanoma.

Interventions

Antigen-specific CAR T, CTL and DCvac to treat melanoma. BIOLOGICAL

Antigen-specific CAR T, CTL and DCvac to treat melanoma.

CAR T/CTL/DCvac cells to treat melanoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86-13671121909; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 18, 2024
• Study Start: August 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)