High-grade GliomaPhase 1NCT06737146
Study of MT027 in Patients with Recurrent or Progressive High-grade Glioma
A Phase 1 study testing MT027 cells suspension in people with High-grade Glioma, run by Suzhou Maximum Bio-tech Co., Ltd. at 1 site in China.
Trial summary
The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose. The injection will be administered once every three weeks, adopting a "3 + 3" dose escalation design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- High-grade Glioma
- What is being tested?
- MT027 cells suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study and sign the informed consent form.
- Be aged between 18 and 70 years old (including the critical values), with no gender limitation.
- Subjects with high-grade glioma diagnosed pathologically (referring to grade 3 or 4 in the "WHO (2021) Classification of Tumors of the Central Nervous System"), who have progressive disease during standard treatment or have recurrence after standard treatment.
- Enhanced MRI shows space-occupying lesions in the brain, and there is at least one measurable lesion (according to the iRANO 2010 version criteria).
- The tumor tissue of the patient has positive expression of B7-H3. The subject voluntarily provides the most recent formalin-fixed paraffin-embedded (FFPE) tissue or pathological sections (at least 8 consecutive blank sections) for the detection of B7-H3 expression (immunohistochemistry, IHC).
- Have an expected survival period of ≥ 3 months.
- Have a Karnofsky Performance Scale (KPS) score of ≥ 70 points. -
Who cannot join
- 1. Patients with recurrence in the brainstem, spinal cord dissemination or extracranial metastasis; 2. The maximum diameter of a single tumor lesion is > 5 cm, or the cumulative maximum diameter of multiple lesions is > 6 cm; 3. Having received radiotherapy within 3 months before cell therapy or having received surgical treatment (except for Ommaya reservoir implantation), chemotherapy (except for lymphocyte depletion therapy), immunotherapy, molecular targeted therapy or any other anti-tumor therapy within 4 weeks before cell therapy; 4. Having participated in other drug clinical trials within 4 weeks before screening; 5. Having previously received CAR-T cell therapy; 6. Subjects with a severe allergy history to any component of the experimental drug or biological products; 7. Subjects with other primary malignancies (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin); 8. Suffering from major diseases such as active systemic infection and coagulation disorders; 9. Suffering from severe insufficiency of heart, lung, liver and kidney functions; cardiac function: grade III or above according to the New York Heart Association (NYHA) criteria; liver function: grade C or above according to the Child-Pugh grading criteria; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; pulmonary function: severe respiratory failure symptoms involving other organs; 10. Subjects with severe autoimmune diseases; 11. Subjects who have previously received allogeneic tissue/solid organ transplantation; 12. Subjects who have received live vaccines within 2 weeks before the first cell therapy or who plan to receive live vaccines during the study period; 13. Subjects with active hepatitis B virus infection; or patients with hepatitis C virus infection (defined as positive HCV antibody, and those with HCV-RNA below the detection limit are allowed to enroll); or patients with human immunodeficiency virus infection (defined as positive HIV antibody); or patients with positive treponema pallidum antibody; 14. Having symptoms and signs of epilepsy or chronic intracranial hypertension that are difficult to control with drugs (for example, those using more than 500 ml of mannitol or more than 15 mg of dexamethasone or more than 80 mg of methylprednisolone or other hormones in equivalent doses per day); 15. Subjects judged by the investigator to have severe neurocognitive disorders; 16. Pregnant or lactating women; 17. Those who are considered by the investigator to be unsuitable for participating in this clinical study due to any clinical or laboratory examination abnormalities or other reasons.
- -
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
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Guangyuan Hu, +8602783663405, h.g.y.121@163.com
Lei Huang, +8615962138334, huanglei@t-maximum.com
About this study
Official title: A Single-arm, Dose-escalation Phase I Clinical Study on Evaluating the Tolerability, Pharmacokinetic Characteristics, Safety and Preliminary Efficacy of MT027 in Patients with Recurrent or Progressive High-grade Glioma
The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose. The injection will be administered once every three weeks, adopting a "3 + 3" dose escalation design. The dosing interval is based on the pharmacokinetic (PK), safety and preliminary efficacy data of MT027 investigator-initiated trial (IIT) previously conducted at Dushu Lake Hospital of Soochow University. Accordingly, it is recommended to maintain the dosing interval of once every three weeks, with a window period of ±7 days. According to past experience, the dosing cycle should be at least 6 cycles, with each cycle lasting 21 days. If patients still benefit after more than 6 cycles, they can continue to receive the medication until no further benefit is achieved. The number of treatment sessions is approximately 6 to 9 times. However, the specific number of treatment sessions will generally be determined by the investigator based on the patient's disease condition.
- Conditions
- High-grade Glioma
- Being tested
- MT027 cells suspension
- Keywords
- MT027, High-grade glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT027 cells suspensionDrug
MT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| MT027 | Experimental | Not described Receives: Drug: MT027 cells suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: through study completion, an average of 1 year
Dose Limiting Toxicity (DLT)
Measured: 28 days
Immune effector cell-associated neurotoxicity syndrome (ICANs)
Measured: through study completion, an average of 1 year
GvHD
Measured: through study completion, an average of 1 year
CRS
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade GliomaStudies 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
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Maximum Bio-tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737146
- Sponsor's protocol ID
- MT027-HGG-002
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Dose-escalation Phase I Clinical Study on Evaluating the Tolerability, Pharmacokinetic Characteristics, Safety and Preliminary Efficacy of MT027 in Patients with Recurrent or Progressive High-grade Glioma
- ClinicalTrials.gov ID
- NCT06737146
- Acronym / sponsor ID
- MT027-HGG-002
- Conditions
- High-grade Glioma
- Keywords
- MT027, High-grade glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Suzhou Maximum Bio-tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Dec 2024 (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 clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose. The injection will be administered once every three weeks, adopting a "3 + 3" dose escalation design. The dosing interval is based on the pharmacokinetic (PK), safety and preliminary efficacy data of MT027 investigator-initiated trial (IIT) previously conducted at Dushu Lake Hospital of Soochow University. Accordingly, it is recommended to maintain the dosing interval of once every three weeks, with a window period of ±7 days. According to past experience, the dosing cycle should be at least 6 cycles, with each cycle lasting 21 days. If patients still benefit after more than 6 cycles, they can continue to receive the medication until no further benefit is achieved. The number of treatment sessions is approximately 6 to 9 times. However, the specific number of treatment sessions will generally be determined by the investigator based on the patient's disease condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT027 | Experimental | Drug: MT027 cells suspension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in this study and sign the informed consent form.
- Be aged between 18 and 70 years old (including the critical values), with no gender limitation.
- Subjects with high-grade glioma diagnosed pathologically (referring to grade 3 or 4 in the "WHO (2021) Classification of Tumors of the Central Nervous System"), who have progressive disease during standard treatment or have recurrence after standard treatment.
- Enhanced MRI shows space-occupying lesions in the brain, and there is at least one measurable lesion (according to the iRANO 2010 version criteria).
- The tumor tissue of the patient has positive expression of B7-H3. The subject voluntarily provides the most recent formalin-fixed paraffin-embedded (FFPE) tissue or pathological sections (at least 8 consecutive blank sections) for the detection of B7-H3 expression (immunohistochemistry, IHC).
Key exclusion criteria (2 listed)
- 1. Patients with recurrence in the brainstem, spinal cord dissemination or extracranial metastasis; 2. The maximum diameter of a single tumor lesion is > 5 cm, or the cumulative maximum diameter of multiple lesions is > 6 cm; 3. Having received radiotherapy within 3 months before cell therapy or having received surgical treatment (except for Ommaya reservoir implantation), chemotherapy (except for lymphocyte depletion therapy), immunotherapy, molecular targeted therapy or any other anti-tumor therapy within 4 weeks before cell therapy; 4. Having participated in other drug clinical trials within 4 weeks before screening; 5. Having previously received CAR-T cell therapy; 6. Subjects with a severe allergy history to any component of the experimental drug or biological products; 7. Subjects with other primary malignancies (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin); 8. Suffering from major diseases such as active systemic infection and coagulation disorders; 9. Suffering from severe insufficiency of heart, lung, liver and kidney functions; cardiac function: grade III or above according to the New York Heart Association (NYHA) criteria; liver function: grade C or above according to the Child-Pugh grading criteria; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; pulmonary function: severe respiratory failure symptoms involving other organs; 10. Subjects with severe autoimmune diseases; 11. Subjects who have previously received allogeneic tissue/solid organ transplantation; 12. Subjects who have received live vaccines within 2 weeks before the first cell therapy or who plan to receive live vaccines during the study period; 13. Subjects with active hepatitis B virus infection; or patients with hepatitis C virus infection (defined as positive HCV antibody, and those with HCV-RNA below the detection limit are allowed to enroll); or patients with human immunodeficiency virus infection (defined as positive HIV antibody); or patients with positive treponema pallidum antibody; 14. Having symptoms and signs of epilepsy or chronic intracranial hypertension that are difficult to control with drugs (for example, those using more than 500 ml of mannitol or more than 15 mg of dexamethasone or more than 80 mg of methylprednisolone or other hormones in equivalent doses per day); 15. Subjects judged by the investigator to have severe neurocognitive disorders; 16. Pregnant or lactating women; 17. Those who are considered by the investigator to be unsuitable for participating in this clinical study due to any clinical or laboratory examination abnormalities or other reasons.
- -
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 |
|---|---|---|
| MT027 cells suspensionMT027: CRISPR/Cas9 edited B7H3-specific allogeneic CAR-T cells | Drug | MT027 |
Primary outcome
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: through study completion, an average of 1 year
Dose Limiting Toxicity (DLT)
Time frame: 28 days
Immune effector cell-associated neurotoxicity syndrome (ICANs)
Time frame: through study completion, an average of 1 year
GvHD
Time frame: through study completion, an average of 1 year
CRS
Time frame: through study completion, an average of 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 17 Dec 2024.
- 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 study testing MT027 cells suspension in people with High-grade Glioma, run by Suzhou Maximum Bio-tech Co., Ltd. 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 7 inclusion and 2 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 17 Dec 2024. 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?
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 Guangyuan Hu (+86-027-83663405, h.g.y.121@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) and Serious Adverse Events (SAE) (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 17 Dec 2024.