MelanomaPhase 1/2NCT07193966
NG2 and DLL3 CAR-T Cells Targeting Melanoma
A Phase 1/2 study testing NG2 and DLL3 CAR-T cells in people with Melanoma, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- NG2 and DLL3 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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.
- 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, their parents or legal guardians must sign an informed consent and assent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of NG2 and DLL3 CAR-T Therapy Targeting Melanoma
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- NG2 and DLL3 CAR-T cells
- Keywords
- melanoma, CAR-T, chimeric antigen receptor, adoptive T cell transfer, NG2, DLL3
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG2 and DLL3 CAR-T cellsBiological
Infusion of NG2 and DLL3-specific CAR-T via intravenous route
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: NG2 and DLL3 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (3)
Anti-tumor effects
Disease status is defined by image scan to get the outcomes such as Complete response/remission (CR), Very good partial response/remission (VGPR), etc.
Measured: 1 year
The persistence of anti-NG2 and DLL3 CAR-T cells
The investigators will monitor the scale of NG2 and DLL3 CAR-T cells in the peripheral blood.
Measured: 1 year
Survival time of the patients
The survival time of the patients treated with the NG2 and DLL3 CAR-T cells will be evaluated
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Shenzhen Geno-Immune Medical InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193966
- Sponsor's protocol ID
- GIMI-IRB-25004
- Status last verified
- Nov 2026
- First submitted
- 12 Sep 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of NG2 and DLL3 CAR-T Therapy Targeting Melanoma
- ClinicalTrials.gov ID
- NCT07193966
- Acronym / sponsor ID
- GIMI-IRB-25004
- Conditions
- Melanoma
- Keywords
- melanoma, CAR-T, chimeric antigen receptor, adoptive T cell transfer, NG2, DLL3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| effectiveness of CAR-T cells targeting NG2 and DLL3 | Experimental | Biological: NG2 and DLL3 CAR-T cellsGene-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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NG2 and DLL3 CAR-T cellsInfusion of NG2 and DLL3-specific CAR-T via intravenous route | Biological | effectiveness of CAR-T cells targeting NG2 and DLL3 |
Primary outcome
Number of patients with adverse events.
Time frame: 3 months
Determine the toxicity profile the NG2 and DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0
3 secondary outcomes
Anti-tumor effects
Time frame: 1 year
The persistence of anti-NG2 and DLL3 CAR-T cells
Time frame: 1 year
Survival time of the patients
Time frame: 3 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NG2 and DLL3 CAR-T cells in people with Melanoma, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.