NG2 and DLL3 CAR-T Cells Targeting Melanoma

NCT07193966 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-25004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility, safety and efficacy of multiple CAR-T cell therapy which targets NG2 and DLL3 surface antigens in patients with relapsed and refractory melanoma.

Conditions

Melanoma

Keywords

melanoma; CAR-T; chimeric antigen receptor; adoptive T cell transfer; NG2; DLL3

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events.

  Determine the toxicity profile the NG2 and DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0

  3 months

Secondary Outcomes (3)

• Anti-tumor effects

  1 year

• The persistence of anti-NG2 and DLL3 CAR-T cells

  1 year

• Survival time of the patients

  3 year

Study Arms (1)

effectiveness of CAR-T cells targeting NG2 and DLL3

EXPERIMENTAL

Gene-modified T cells are designed to kill tumor cells through specific recognition of NG2 and DLL3. This study will evaluate the side effects and effective doses of NG2 and DLL3 CAR-T cells in treating refractory and recurrent melanoma

Biological: NG2 and DLL3 CAR-T cells

Interventions

NG2 and DLL3 CAR-T cells BIOLOGICAL

Infusion of NG2 and DLL3-specific CAR-T via intravenous route

effectiveness of CAR-T cells targeting NG2 and DLL3

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 tumors have received standard first-line therapy and have been diagnosed with non-resectable, metastatic, progressive or recurrent conditions.
• The expression status of NG2 and DLL3 antigens of the tumor has been determined for eligibility. Positive expression is defined by NG2 and DLL3 antibody staining results based on immunohistochemistry or flow cytometry analyses.
• 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 have 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 6 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 CART 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 0755-86573763; 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: September 12, 2025
• First Posted: September 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)