Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-04 @ 9:42 AM
Study NCT ID:
NCT07193966
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NG2 and DLL3 CAR-T Cells Targeting Melanoma
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Study Overview
Official Title:
Safety and Efficacy of NG2 and DLL3 CAR-T Therapy Targeting Melanoma
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Melanoma, known for having the highest mutation burden among solid tumors, is in a steady rise in incidence over recent years. Early-stage melanoma can be treated by surgery. As the tumor invades deeper and cancer cells metastasize, the difficulty of radical surgery increases, and melanoma is highly resistant to conventional chemotherapy and radiation therapy. In this context, immunotherapy has become a new area of exploration.
NG2 (chondroitin sulfate protein polysaccharide 4) is a cell surface type I transmembrane proteoglycan with substantial advantages as a potential therapeutic target for melanoma. On one hand, it exhibits strong targeting specificity, showing high expression in melanoma cells and in tumor angiogenesis-related blood vessels while maintaining low expression in normal tissues. This enables its targeted delivery to tumor sites, reducing damage to healthy tissues and minimizing side effects. On the other hand, NG2 involves multiple mechanisms: it not only participates in melanoma cell proliferation and survival but also plays a crucial role in tumor angiogenesis. Targeting NG2 may simultaneously inhibit both tumor cell growth and angiogenesis. Additionally, NG2 demonstrates prognostic value, as studies show its high expression correlates with better disease-free survival (DFS) in melanoma patients. This makes it a prognostic marker that helps assess disease progression and prognosis, providing valuable insights for treatment regimen formulation.
Another potential therapeutic target, delta-like ligand 3 (DLL3), demonstrates three key advantages: first, it exhibits high targeting specificity - showing low expression in normal tissues but high expression in melanoma cells. This enables precision targeting by related drugs (such as antibody conjugates ADCs and CAR-T) to effectively attack tumors while minimizing damage to healthy tissues and reducing toxic side effects. Second, it restoring Notch signaling to inhibit tumor cell growth while blocking angiogenesis and epithelial mesenchymal transition (EMT), thereby suppressing cancer progression from both cellular and microenvironmental dimensions. Third, it shows broad clinical prospects, serving as a prognostic marker to guide personalized treatment and providing new therapeutic options for DLL3-positive patients with poor response to PD-1 inhibitors, potentially breaking through the treatment bottleneck in advanced melanoma.
The purpose of this clinical study is to assess the feasibility, safety and efficacy of the combinational NG2 and DLL3 CAR T cell immunotherapy in patients who have melanoma in relapsed state or late stage.
NG2 (chondroitin sulfate protein polysaccharide 4) is a cell surface type I transmembrane proteoglycan with substantial advantages as a potential therapeutic target for melanoma. On one hand, it exhibits strong targeting specificity, showing high expression in melanoma cells and in tumor angiogenesis-related blood vessels while maintaining low expression in normal tissues. This enables its targeted delivery to tumor sites, reducing damage to healthy tissues and minimizing side effects. On the other hand, NG2 involves multiple mechanisms: it not only participates in melanoma cell proliferation and survival but also plays a crucial role in tumor angiogenesis. Targeting NG2 may simultaneously inhibit both tumor cell growth and angiogenesis. Additionally, NG2 demonstrates prognostic value, as studies show its high expression correlates with better disease-free survival (DFS) in melanoma patients. This makes it a prognostic marker that helps assess disease progression and prognosis, providing valuable insights for treatment regimen formulation.
Another potential therapeutic target, delta-like ligand 3 (DLL3), demonstrates three key advantages: first, it exhibits high targeting specificity - showing low expression in normal tissues but high expression in melanoma cells. This enables precision targeting by related drugs (such as antibody conjugates ADCs and CAR-T) to effectively attack tumors while minimizing damage to healthy tissues and reducing toxic side effects. Second, it restoring Notch signaling to inhibit tumor cell growth while blocking angiogenesis and epithelial mesenchymal transition (EMT), thereby suppressing cancer progression from both cellular and microenvironmental dimensions. Third, it shows broad clinical prospects, serving as a prognostic marker to guide personalized treatment and providing new therapeutic options for DLL3-positive patients with poor response to PD-1 inhibitors, potentially breaking through the treatment bottleneck in advanced melanoma.
The purpose of this clinical study is to assess the feasibility, safety and efficacy of the combinational NG2 and DLL3 CAR T cell immunotherapy in patients who have melanoma in relapsed state or late stage.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: