Brain Metastases From Solid TumorsPhase 2METAMAX-101NCT07897799
The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors
A Phase 2 study testing Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3 in people with Brain Metastases From Solid Tumors, run by T-MAXIMUM Pharmaceutical Inc at 2 sites in 2 countries.
Trial summary
This is a prospective, open-label, multicenter, single arm Phase II trial to evaluate the safety, tolerability, intracranial efficacy, pharmacokinetics, and pharmacodynamics of MT027 administered ICV in patients with B7-H3-positive brain metastases from advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases From Solid Tumors
- What is being tested?
- Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Dec 2027to 20 Dec 2030
- Phase
- Phase 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- signed informed consent obtained before any study procedure.
- Histologically/cytologically confirmed advanced solid tumor with brain metastases.
- ≥1 measurable brain parenchymal lesion (≥5 mm on MRI).
- B7-H3 positive expression in tumor tissue by central IHC.
- CNS disease progressed after, unsuitable for, or not requiring immediate standard local therapy (SRS/WBRT/surgery), per investigator and multidisciplinary review.
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- Previously received, intolerant to, or ineligible for any CNS-active targeted therapy for actionable driver alterations.
- Extracranial disease stable ≥8 weeks and not requiring systemic therapy change; non-ADC chemotherapy discontinued ≥3 weeks before study treatment.
- Prior CNS local therapy permitted, provided the target lesion shows clear progression and does not overlap a previously treated SRS field (≥2-week interval).
- Treatment-related toxicities resolved to ≤Grade 1 or baseline (alopecia, ≤Grade 2 neuropathy, and specified lab values permitted).
- ECOG 0-2 and life expectancy ≥12 weeks.
- Adequate organ and marrow function (ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hgb ≥90 g/L, AST/ALT ≤3×ULN, TBili ≤1.5×ULN, Cr ≤1.5×ULN or CrCl ≥30 mL/min, INR/APTT ≤1.5×ULN, LVEF >50%, SpO₂ ≥95%).
- Effective contraception from screening through 120 days after last dose; negative pregnancy test within 72 hours before first dose (for WOCBP).
Who cannot join
- CNS disease requiring urgent intervention (mass effect, herniation, hemorrhage, hydrocephalus, progressive neurologic symptoms); uncontrolled seizures or antiepileptic escalation within 4 weeks.
- Target lesion >4 cm, unsafe location, or CNS tumor burden posing unacceptable risk.
- Leptomeningeal metastasis.
- Active autoimmune disease requiring systemic treatment (type 1 DM, hypothyroidism on replacement, and non-systemic skin disorders permitted).
- Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, coagulation, or neurologic disease.
- Active uncontrolled infection or HBV/HCV/HIV/syphilis.
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- Active pulmonary tuberculosis within 1 year prior to study treatment.
- Other investigational therapy within 4 weeks or 5 half-lives, whichever is longer.
- Prior allogeneic transplant or CAR-T / other gene-modified cell therapy.
- Systemic immunosuppression within 4 weeks, or corticosteroids >dexamethasone 2 mg/day (or equivalent) / not stabilized ≤2 mg/day for ≥7 days.
- Live vaccine within 2 weeks before, or planned during, study treatment. Inability to safely undergo ICV / Ommaya reservoir procedures.
- VP shunt or other CSF diversion device.
- Major surgery, open biopsy, or significant trauma within 2 weeks (Ommaya placement excepted; wounds must be fully healed).
- Known hypersensitivity to any component of the study intervention.
- Unlikely to comply with follow-up or protocol procedures, or any condition that, in the investigator's judgment, compromises safety or participation.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Taiwan1 site
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taoyuan, 333423
Wei Kuo Chen
About this study
Official title: A Phase II, Open-label, Multicenter Trial With a Safety Run-in to Evaluate the Safety, Tolerability, Intracranial Efficacy, Pharmacokinetics, and Pharmacodynamics of MT027 Administered Intracerebroventricularly in Patients With B7-H3-positive Brain Metastases From Advanced Solid Tumors
This is a prospective, open-label, multicenter, single arm Phase II trial to evaluate the safety, tolerability, intracranial efficacy, pharmacokinetics, and pharmacodynamics of MT027 administered ICV in patients with B7-H3-positive brain metastases from advanced solid tumors.
The trial consists of two sequential stages: a safety run-in stage followed by a dose expansion stage. Approximately 40 participants are planned for enrollment, including approximately 3 to 6 participants in the safety run in stage and 34 participants in the dose expansion stage. The final number of participants enrolled may vary depending on the safety findings observed during the safety run-in stage.
Read more
Approximately 3 to 6 eligible participants from the primary target population will receive MT027 3×107 CAR+ T cells via ICV injection on Days 1 and 15 of each 28-day cycle. DLTs will be assessed during a 28-day DLT observation period following the first dose.
Following SRC confirmation of acceptable safety during the safety run-in stage, an additional 34 participants will be enrolled to evaluate the intracranial efficacy of MT027 dosed at 3×107 CAR+ T cells.
- Conditions
- Brain Metastases From Solid Tumors
- Being tested
- Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3Biological
MT027 will be injected intracerebroventricularly at a dose of 3×10^7 cells on Day 1 \& Day 15 of each 28-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| MT027 | Experimental | Intracerebroventricular administration of MT027 (3×10^7 B7-H3 Targeted UCAR-T-cell) Receives: Biological: Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Dose-limiting toxicity (DLT)
Incidence rate of Dose-limiting toxicity (DLT) after treatment in the safety run-in stage
Measured: up to 28 days
Intracranial progression-free survival at 6 months (iPFS6)
defined as the time from treatment initiation to disease progression in central nervous system (CNS), or death, whichever occurs first, or considered censored at the end of follow-up.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Dec 2027 (estimated)
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Metastases From Solid TumorsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intracerebroventricular administration of 3×10\^7 cells of MT027
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T-MAXIMUM Pharmaceutical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897799
- Sponsor's protocol ID
- METAMAX-101
- Acronym
- METAMAX-101
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multicenter Trial With a Safety Run-in to Evaluate the Safety, Tolerability, Intracranial Efficacy, Pharmacokinetics, and Pharmacodynamics of MT027 Administered Intracerebroventricularly in Patients With B7-H3-positive Brain Metastases From Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07897799
- Acronym / sponsor ID
- METAMAX-101 / METAMAX-101
- Conditions
- Brain Metastases From Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- T-MAXIMUM Pharmaceutical IncIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2027 (estimated)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Dec 2030 (estimated)
- First posted
- 27 Oct 2026 (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 is a prospective, open-label, multicenter, single arm Phase II trial to evaluate the safety, tolerability, intracranial efficacy, pharmacokinetics, and pharmacodynamics of MT027 administered ICV in patients with B7-H3-positive brain metastases from advanced solid tumors.
The trial consists of two sequential stages: a safety run-in stage followed by a dose expansion stage. Approximately 40 participants are planned for enrollment, including approximately 3 to 6 participants in the safety run in stage and 34 participants in the dose expansion stage. The final number of participants enrolled may vary depending on the safety findings observed during the safety run-in stage.
Approximately 3 to 6 eligible participants from the primary target population will receive MT027 3×107 CAR+ T cells via ICV injection on Days 1 and 15 of each 28-day cycle. DLTs will be assessed during a 28-day DLT observation period following the first dose.
Following SRC confirmation of acceptable safety during the safety run-in stage, an additional 34 participants will be enrolled to evaluate the intracranial efficacy of MT027 dosed at 3×107 CAR+ T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intracerebroventricular administration of 3×10^7 cells of MT027
| Arm | Type | Receives |
|---|---|---|
| MT027 | Experimental | Biological: Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3Intracerebroventricular administration of MT027 (3×10^7 B7-H3 Targeted UCAR-T-cell) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years.
- signed informed consent obtained before any study procedure.
- Histologically/cytologically confirmed advanced solid tumor with brain metastases.
- ≥1 measurable brain parenchymal lesion (≥5 mm on MRI).
- B7-H3 positive expression in tumor tissue by central IHC.
Key exclusion criteria (15 listed)
- CNS disease requiring urgent intervention (mass effect, herniation, hemorrhage, hydrocephalus, progressive neurologic symptoms); uncontrolled seizures or antiepileptic escalation within 4 weeks.
- Target lesion >4 cm, unsafe location, or CNS tumor burden posing unacceptable risk.
- Leptomeningeal metastasis.
- Active autoimmune disease requiring systemic treatment (type 1 DM, hypothyroidism on replacement, and non-systemic skin disorders permitted).
- Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, coagulation, or neurologic disease.
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 |
|---|---|---|
| Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3MT027 will be injected intracerebroventricularly at a dose of 3×10^7 cells on Day 1 \& Day 15 of each 28-day treatment cycle. | Biological | MT027 |
Primary outcome
Incidence rate of Dose-limiting toxicity (DLT)
Time frame: up to 28 days
Incidence rate of Dose-limiting toxicity (DLT) after treatment in the safety run-in stage
Intracranial progression-free survival at 6 months (iPFS6)
Time frame: up to 6 months
defined as the time from treatment initiation to disease progression in central nervous system (CNS), or death, whichever occurs first, or considered censored at the end of follow-up.
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 27 Oct 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3 in people with Brain Metastases From Solid Tumors, run by T-MAXIMUM Pharmaceutical Inc at 2 sites in 2 countries.
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 13 inclusion and 15 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 27 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 2 sites in United States, Taiwan. 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 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 Dan Wang Wang (18914076852, wangdan@t-maximum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of Dose-limiting toxicity (DLT) (time frame: up to 28 days). The study lists 2 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 27 Oct 2026.