Glioblastoma of CerebellumPhase 1/2NCT07180927
DLL3 CAR-T Therapy Targeting Brain Tumors
A Phase 1/2 study testing 4SCAR DLL3 T cells in people with Glioblastoma of Cerebellum, 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 Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Glioblastoma of Cerebellum
- What is being tested?
- 4SCAR DLL3 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2027to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- abilities to understand and the willingness to provide written informed consent;
- patients are ≥ 2 and ≤ 70 years old;
- recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
- Karnofsky performance score (KPS) ≥ 60;
- life expectancy >3 months;
- satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm^3; hemoglobin > 10 g/dL; platelets > 100000 /mm^3; Bilirubin < 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5×ULN; creatinine < 1.5×ULN;
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- peripheral blood absolute lymphocyte count must be above 0.8×10^9/L;
- satisfactory heart functions;
- patients must be willing to follow the instructions of doctors;
- women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.
Who cannot join
- a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;
- HIV positive;
- tuberculosis infection not under control;
- history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
- history of allergic disease, or allergy to immune cells or study product excipients;
- patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Geno-immuno Medical Institute
Shenzhen, Guangdong, 518000
Lung-Ji Chang, PhD, +86-13671121909, c@mkgimi.com
About this study
Official title: 4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors
The purpose of this study is to assess the feasibility, safety and efficacy of Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.
Read the detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Glioblastoma (GBM) and other aggressive brain tumors remain among the most challenging cancers to treat, with limited therapeutic options and poor survival rates. GBM is known to express increased levels of certain antigens that can be targeted by T cells including chimeric antigen receptor-modified T (CAR-T) cells.
One promising target in this effort is DLL3, a protein highly expressed on the surface of certain tumor cells including GBM/DIPG/DMG and other central nervous system malignancies but with minimal presence in normal tissues. This expression pattern makes DLL3 an attractive target for precision CAR-T therapy treating brain tumors, which involves engineering a patient's own T cells to recognize and eliminate cancer cells expressing this specific marker.
This study aims to evaluate the safety, feasibility, and preliminary efficacy of DLL3-directed CAR-T cells in patients with recurrent or refractory brain tumors. These studies represent a critical step toward harnessing the immune system to fight traditionally treatment-resistant cancers, offering new hope for patients with few other options.
- Conditions
- Glioblastoma of Cerebellum
- Being tested
- 4SCAR DLL3 T cells
- Keywords
- CAR-T, Glioblastoma, DLL3
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4SCAR DLL3 T cellsBiological
Infusion of 4SCAR DLL3 T cells at 10^6 cells/kg body weight via intravenous route
| Study group | Role | What they receive |
|---|---|---|
| 4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma | Experimental | Infusion of 4SCAR-DLL3 T cells at 10^6 cells/kg body weight via intravenous route Receives: Biological: 4SCAR DLL3 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 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0
Measured: 6 months
Secondary outcomes (4)
Anti-tumor effects
Objective responses (complete response (CR) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.
Measured: 1 year
Anti-tumor effects
Objective responses partial response (PR)) are assessed by the Response Evaluation Criteria in Glioblastoma (RECIST) v1.1 criteria.
Measured: 1 year
The expansion of 4SCAR DLL3 T cells
Scale of CAR copies for efficacy
Measured: 1 year
The persistence of 4SCAR DLL3 T cells
Scale of tumor burden for efficacy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jun 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma of CerebellumStudies 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
- 30 participants (estimated)
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
- NCT07180927
- Sponsor's protocol ID
- GIMI-IRB-25003
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 2 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors
- ClinicalTrials.gov ID
- NCT07180927
- Acronym / sponsor ID
- GIMI-IRB-25003
- Conditions
- Glioblastoma of Cerebellum
- Keywords
- CAR-T, Glioblastoma, DLL3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 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 Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.
Detailed description
Important Regulatory Notice:
This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.
ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.
Glioblastoma (GBM) and other aggressive brain tumors remain among the most challenging cancers to treat, with limited therapeutic options and poor survival rates. GBM is known to express increased levels of certain antigens that can be targeted by T cells including chimeric antigen receptor-modified T (CAR-T) cells.
One promising target in this effort is DLL3, a protein highly expressed on the surface of certain tumor cells including GBM/DIPG/DMG and other central nervous system malignancies but with minimal presence in normal tissues. This expression pattern makes DLL3 an attractive target for precision CAR-T therapy treating brain tumors, which involves engineering a patient's own T cells to recognize and eliminate cancer cells expressing this specific marker.
This study aims to evaluate the safety, feasibility, and preliminary efficacy of DLL3-directed CAR-T cells in patients with recurrent or refractory brain tumors. These studies represent a critical step toward harnessing the immune system to fight traditionally treatment-resistant cancers, offering new hope for patients with few other options.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma | Experimental | Biological: 4SCAR DLL3 T cellsInfusion of 4SCAR-DLL3 T cells at 10^6 cells/kg body weight via intravenous route |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- abilities to understand and the willingness to provide written informed consent;
- patients are ≥ 2 and ≤ 70 years old;
- recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
- Karnofsky performance score (KPS) ≥ 60;
- life expectancy >3 months;
Key exclusion criteria (6 listed)
- a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;
- HIV positive;
- tuberculosis infection not under control;
- history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
- history of allergic disease, or allergy to immune cells or study product excipients;
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 |
|---|---|---|
| 4SCAR DLL3 T cellsInfusion of 4SCAR DLL3 T cells at 10^6 cells/kg body weight via intravenous route | Biological | 4SCAR-DLL3 T Cell Therapy treating DLL3 positive glioblastoma |
Primary outcome
Number of patients with adverse events.
Time frame: 6 months
Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0
4 secondary outcomes
Anti-tumor effects
Time frame: 1 year
Anti-tumor effects
Time frame: 1 year
The expansion of 4SCAR DLL3 T cells
Time frame: 1 year
The persistence of 4SCAR DLL3 T cells
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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.
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 4SCAR DLL3 T cells in people with Glioblastoma of Cerebellum, 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 10 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lung-Ji Chang, PhD (+86 0755-86573763, c@mkgimi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events. (time frame: 6 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 2 Nov 2026.