Glioblastoma Multiforme of BrainPhase 1NCT03170141
Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme
A Phase 1 study testing Antigen-specific IgT cells in people with Glioblastoma Multiforme of Brain and Brain Cancer, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial summary
This study aims to treat patients who have been diagnosed with brain cancer glioblastoma multiforme (GBM) including diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG). The treatment combines two different approaches to fight cancer: immune modulators and antigen-specific T cells. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme of Brain, Brain Cancer
- What is being tested?
- Antigen-specific IgT 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
- 31 May 2017to 31 Jul 2026
- Phase
- Phase 1
- 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 6 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 ≥ 6 and ≤ 70 years old;
- recurrent glioblastoma or brain tumor patients with measurable tumors. 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 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.
About this study
Official title: Immunogene-modified Antigen-specific T (IgT) Cells for the Treatment of Glioblastoma Multiforme
This study aims to treat patients who have been diagnosed with brain cancer glioblastoma multiforme (GBM) including diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG). The treatment combines two different approaches to fight cancer: immune modulators and antigen-specific T cells. Immune checkpoint antibodies have been tested on various tumors with good outcomes. 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 and tumor antigen specific cytotoxic lymphocytes (CTLs). In this study, the gene-modified T cells specific for GBM antigens will be combined with immune modulatory gene-modified dendritic cells (DCs) as individualized treatment regimens to treat patients.
Read the detailed description
Background:
Glioblastoma multiforme (GBM) is the most dangerous and aggressive form of brain cancer. Chimeric antigen receptor (CAR)-modified T cells have been shown to mediate long-term durable remissions in recurrent or refractory hematopoietic malignancies, and thus the CAR-T therapy approach is also considered a promising treatment against GBM. Some surface antigens such as GD2 and CD56 have been targeted as potential GBM antigens. In addition, certain antigens are highly specific in GBM, such as epidermal growth factor receptor variant EGFRviii and metastasis related antigen CD44v6.
Tumor microenvironment is known to suppressive anti-cancer immune responses. Many immune checkpoint inhibitors have demonstrated marked anti-tumor activities. For example, CD276 is a member of the B7 family of immune checkpoint proteins, and CD276-specific CAR-T cell therapy have been considered a potential brain tumor microenvironment treatment. Besides immune checkpoint inhibitor antibodies, antigen-specific T cells modified with immune modulatory genes (IgT) such as genes encoding immune checkpoint inhibitors may be applied. Combination of tumor targeting and immune modulatory activities, the IgT cells could target both the tumor cells and the tumor microenvironment.
- Conditions
- Glioblastoma Multiforme of Brain, Brain Cancer
- Being tested
- Antigen-specific IgT cells
- Keywords
- CAR T, Gene Therapy, GBM, GD2, CD276, PD1
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigen-specific IgT cellsBiological
Tumor antigen-specific IgT cells are infused intravenously . Drug: cyclophosphamide 250 mg/m^2 d1-3; Drug: Fludarabine 25mg/m^2 d1-3
| Study group | Role | What they receive |
|---|---|---|
| Antigen-specific IgT cells | Experimental | Patients will receive non-myeloablative chemotherapy consisting of fludarabine and cyclophosphamide, followed by intravenous infusion of autologous IgT cells. The tested IgT cell dosage ranges from 5×10^5 /kg to 5×10^6 /kg Receives: Biological: Antigen-specific IgT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of infusion of autologous IgT cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria.
incidents of treatment related adverse events as assessed by CTCAE V4.0.
Measured: 1 years
Secondary outcomes (4)
Treatment response rate of recurrent glioblastoma
Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD).
Measured: 6 months
Overall survival Rate
Percentage of participants with objective response as determined by the investigator based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)
Measured: 2 years
Progression-free survival rate
Progression-free Survival (PFS) as determined by the investigator based on RECIST v1.1
Measured: 2 years
Persistence and proliferation of IgT cells in patients
IgT cell percentage in the peripheral blood by qPCR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start31 May 2017
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma Multiforme of BrainStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with GBM will be treated with tumor targeting IgT cells including CAR-T cells
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
- Investigators
- Lung-Ji Chang, PhD, Principal investigator, Shenzhen Geno-Immune Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170141
- Sponsor's protocol ID
- GIMI-IRB-17003
- Status last verified
- Oct 2026
- First submitted
- 25 May 2017
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Z, Zhou J, Yang X, Liu Y, Zou C, Lv W, Chen C, Cheng KK, Chen T, Chang LJ, Wu D, Mao J. Safety and antitumor activity of GD2-Specific 4SCAR-T cells in patients with glioblastoma. Mol Cancer. 2023 Jan 9;22(1):3. doi: 10.1186/s12943-022-01711-9.
PubMed 36617554
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogene-modified Antigen-specific T (IgT) Cells for the Treatment of Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT03170141
- Acronym / sponsor ID
- GIMI-IRB-17003
- Conditions
- Glioblastoma Multiforme of Brain, Brain Cancer
- Keywords
- CAR T, Gene Therapy, GBM, GD2, CD276, PD1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 30 May 2017 (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.
This study aims to treat patients who have been diagnosed with brain cancer glioblastoma multiforme (GBM) including diffuse intrinsic pontine glioma (DIPG) and diffuse midline glioma (DMG). The treatment combines two different approaches to fight cancer: immune modulators and antigen-specific T cells. Immune checkpoint antibodies have been tested on various tumors with good outcomes. 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 and tumor antigen specific cytotoxic lymphocytes (CTLs). In this study, the gene-modified T cells specific for GBM antigens will be combined with immune modulatory gene-modified dendritic cells (DCs) as individualized treatment regimens to treat patients.
Detailed description
Background:
Glioblastoma multiforme (GBM) is the most dangerous and aggressive form of brain cancer. Chimeric antigen receptor (CAR)-modified T cells have been shown to mediate long-term durable remissions in recurrent or refractory hematopoietic malignancies, and thus the CAR-T therapy approach is also considered a promising treatment against GBM. Some surface antigens such as GD2 and CD56 have been targeted as potential GBM antigens. In addition, certain antigens are highly specific in GBM, such as epidermal growth factor receptor variant EGFRviii and metastasis related antigen CD44v6.
Tumor microenvironment is known to suppressive anti-cancer immune responses. Many immune checkpoint inhibitors have demonstrated marked anti-tumor activities. For example, CD276 is a member of the B7 family of immune checkpoint proteins, and CD276-specific CAR-T cell therapy have been considered a potential brain tumor microenvironment treatment. Besides immune checkpoint inhibitor antibodies, antigen-specific T cells modified with immune modulatory genes (IgT) such as genes encoding immune checkpoint inhibitors may be applied. Combination of tumor targeting and immune modulatory activities, the IgT cells could target both the tumor cells and the tumor microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with GBM will be treated with tumor targeting IgT cells including CAR-T cells
| Arm | Type | Receives |
|---|---|---|
| Antigen-specific IgT cells | Experimental | Biological: Antigen-specific IgT cellsPatients will receive non-myeloablative chemotherapy consisting of fludarabine and cyclophosphamide, followed by intravenous infusion of autologous IgT cells. The tested IgT cell dosage ranges from 5×10^5 /kg to 5×10^6 /kg |
Who may qualify
- Ages
- 6 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 ≥ 6 and ≤ 70 years old;
- recurrent glioblastoma or brain tumor patients with measurable tumors. 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 (7 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 |
|---|---|---|
| Antigen-specific IgT cellsTumor antigen-specific IgT cells are infused intravenously . Drug: cyclophosphamide 250 mg/m^2 d1-3; Drug: Fludarabine 25mg/m^2 d1-3 | Biological | Antigen-specific IgT cells |
Primary outcome
Safety of infusion of autologous IgT cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria.
Time frame: 1 years
incidents of treatment related adverse events as assessed by CTCAE V4.0.
4 secondary outcomes
Treatment response rate of recurrent glioblastoma
Time frame: 6 months
Overall survival Rate
Time frame: 2 years
Progression-free survival rate
Time frame: 2 years
Persistence and proliferation of IgT cells in patients
Time frame: 2 years
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 30 Oct 2026.
- Derived from this study: PubMed 36617554Liu Z, Zhou J, Yang X, Liu Y, Zou C, Lv W, Chen C, Cheng KK, Chen T, Chang LJ, Wu D, Mao J. Safety and antitumor activity of GD2-Specific 4SCAR-T cells in patients with glioblastoma. Mol Cancer. 2023 Jan 9;22(1):3. doi: 10.1186/s12943-022-01711-9.
- 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.
Lung-Ji Chang, PhD principal investigator
Shenzhen Geno-Immune Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Antigen-specific IgT cells in people with Glioblastoma Multiforme of Brain and Brain Cancer, 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 7 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 30 Oct 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 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.
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?
Safety of infusion of autologous IgT cells with cyclophosphamide and fludarabine as lymphodepleting chemotherapy in patients with recurrent glioblastoma using the NCI CTCAE V4.0 criteria. (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170141, which also lists 1 linked publication.
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 30 Oct 2026.