Brain (Nervous System) CancersPhase 1NCT06742593
Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors
A Phase 1 study testing MT027 cells suspension in people with Brain (Nervous System) Cancers and Brain and Central Nervous System Tumors, run by Suzhou Maximum Bio-tech Co., Ltd. at 1 site in China.
Trial summary
MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain (Nervous System) Cancers, Brain and Central Nervous System Tumors, Brain Tumors
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study and provide a signed and dated written informed consent form prior to any study-specific procedures, sampling or analyses.
- Be aged 18 years or older, with no limitation on gender.
- Have a definite diagnosis of malignant tumor confirmed by pathology and/or histology (and provide complete pathological report information), and have been verified by biopsy, cytology, imaging examinations, etc. or have had previous confirmation of brain, meninges, spinal cord metastases, including lung cancer, breast cancer, colorectal cancer, melanoma, renal cell carcinoma, etc. Other solid tumor CNS metastases without standard treatment as judged by the investigator can also be considered for enrollment.
- The expected survival period is at least 3 months.
- The Karnofsky Performance Scale (KPS) score is ≥ 70 points. -
Who cannot join
- Known to be allergic to the investigational drug or its excipient components;
- Those with central nervous system metastases of hematological malignancies (such as lymphoma, leukemia, etc.);
- Those with metastases in the brainstem and high cervical spinal cord, including the midbrain, pons, medulla oblongata and C1/2 cervical spinal cord segments;
- Those with 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;
- Pregnant or lactating women;
- 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
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100029
Shuhang Wang, +86-010-87788713, snowflake201@gmail.com
About this study
Official title: A Single-arm, Dose-escalating Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic , and Efficacy of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors
MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of patients who have a demand for CAR-T therapy but cannot receive it due to the common reasons of long production cycle, insufficient production capacity, and incompatibility of patients' T cells with the production conditions. In addition, the expected medical cost of allogeneic CAR-T cells is significantly lower, which can greatly alleviate the economic burden on patients.
MT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology. MT027 products targeting the B7H3 target developed by Moxing Biotech avoid the potential graft-versus-host disease (GvHD) and host anti-graft reaction (HvGR) caused by the interaction between exogenous T cells and the patient's immune system, and have shown good safety and efficacy in recurrent high-grade glioma in the initial phase.
Read the detailed description
This study adopted a single-arm, open-label, single-center clinical trial design. The study population consisted of patients with high-grade glioma, aged 18 - 70 years old, whose B7H3 antigen expression was positive and had been confirmed by histology or cytology, and who had recurrence or progression after standard treatment. Subjects received local injection administration (intraventricular administration via an Ommaya reservoir or intrathecal administration into the lumbar cistern through lumbar puncture). For intrathecal injection via lumbar puncture, the dosage for each administration was divided into four dose levels: 1.0, 1.5, 2, 2.5 × 10⁷ cells per time, and the administration frequency was once every 4 weeks.
During the study period, adverse events were observed and recorded, with special attention paid to product-specific adverse reactions such as graft-versus-host disease (GvHD), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). Cerebrospinal fluid (CSF) and blood samples were collected to analyze PK and PD indicators such as CAR copy numbers and cytokines in the samples. Efficacy evaluations were conducted once per cycle, and efficacy indicators such as overall survival (OS), 12-month overall survival rate (12m-OS), objective response rate (ORR), and disease control rate (DCR) were calculated.
- Being tested
- MT027 cells suspension
- Medical subject headings
- Neurologic Manifestations, Neoplasms, Central Nervous System Neoplasms, Brain Neoplasms
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
Graft-versus-host Disease (GvHD)
Measured: through study completion, an average of 1 year
Cytokine Release Syndrome (CRS)
Measured: through study completion, an average of 1 year
Immune effector cell-associated neurotoxicity syndrome (ICANs)
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 posted19 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Dec 2025 (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 Brain (Nervous System) CancersStudies 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
- Investigators
- Ning Li, MD/phD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742593
- Sponsor's protocol ID
- MT027-BSM-001
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 19 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Dose-escalating Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic , and Efficacy of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06742593
- Acronym / sponsor ID
- MT027-BSM-001
- 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 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 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.
MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of patients who have a demand for CAR-T therapy but cannot receive it due to the common reasons of long production cycle, insufficient production capacity, and incompatibility of patients' T cells with the production conditions. In addition, the expected medical cost of allogeneic CAR-T cells is significantly lower, which can greatly alleviate the economic burden on patients.
MT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology. MT027 products targeting the B7H3 target developed by Moxing Biotech avoid the potential graft-versus-host disease (GvHD) and host anti-graft reaction (HvGR) caused by the interaction between exogenous T cells and the patient's immune system, and have shown good safety and efficacy in recurrent high-grade glioma in the initial phase.
Detailed description
This study adopted a single-arm, open-label, single-center clinical trial design. The study population consisted of patients with high-grade glioma, aged 18 - 70 years old, whose B7H3 antigen expression was positive and had been confirmed by histology or cytology, and who had recurrence or progression after standard treatment. Subjects received local injection administration (intraventricular administration via an Ommaya reservoir or intrathecal administration into the lumbar cistern through lumbar puncture). For intrathecal injection via lumbar puncture, the dosage for each administration was divided into four dose levels: 1.0, 1.5, 2, 2.5 × 10⁷ cells per time, and the administration frequency was once every 4 weeks.
During the study period, adverse events were observed and recorded, with special attention paid to product-specific adverse reactions such as graft-versus-host disease (GvHD), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). Cerebrospinal fluid (CSF) and blood samples were collected to analyze PK and PD indicators such as CAR copy numbers and cytokines in the samples. Efficacy evaluations were conducted once per cycle, and efficacy indicators such as overall survival (OS), 12-month overall survival rate (12m-OS), objective response rate (ORR), and disease control rate (DCR) were calculated.
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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily participate in this study and provide a signed and dated written informed consent form prior to any study-specific procedures, sampling or analyses.
- Be aged 18 years or older, with no limitation on gender.
- Have a definite diagnosis of malignant tumor confirmed by pathology and/or histology (and provide complete pathological report information), and have been verified by biopsy, cytology, imaging examinations, etc. or have had previous confirmation of brain, meninges, spinal cord metastases, including lung cancer, breast cancer, colorectal cancer, melanoma, renal cell carcinoma, etc. Other solid tumor CNS metastases without standard treatment as judged by the investigator can also be considered for enrollment.
- The expected survival period is at least 3 months.
- The Karnofsky Performance Scale (KPS) score is ≥ 70 points. -
Key exclusion criteria (6 listed)
- Known to be allergic to the investigational drug or its excipient components;
- Those with central nervous system metastases of hematological malignancies (such as lymphoma, leukemia, etc.);
- Those with metastases in the brainstem and high cervical spinal cord, including the midbrain, pons, medulla oblongata and C1/2 cervical spinal cord segments;
- Those with 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;
- Pregnant or lactating women;
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
Graft-versus-host Disease (GvHD)
Time frame: through study completion, an average of 1 year
Cytokine Release Syndrome (CRS)
Time frame: through study completion, an average of 1 year
Immune effector cell-associated neurotoxicity syndrome (ICANs)
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 19 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.
Ning Li, MD/phD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 Brain (Nervous System) Cancers and Brain and Central Nervous System Tumors, 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 5 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 19 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 Shuhang Wang, MD/phD (+86-01087788713, snowflake201@gmail.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 19 Dec 2024.