Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypePhase 2GLIOMAX-101NCT07386002
The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma
A Phase 2 study testing Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3 in people with Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by T-MAXIMUM Pharmaceutical Inc at 4 sites in 2 countries.
Trial summary
This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- 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
- 4 sitesin 2 countries
- Study dates
- 30 Nov 2026to 31 Jul 2029
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following inclusion criteria to be enrolled in the study (applied to all patients screened in safety run-in and dose expansion stage, unless specified):
- Written informed consent must be obtained prior to any procedures that are not considered SOC
- ≥ 18 years old and ≤ 70 years old on the day of signing informed consent, male or female
- According to the WHO Classification of Tumors of the CNS (2021), definitely diagnosed recurrent or progressive GBM, WHO Grade 4, which must meet all 3 of the following criteria:
- According to the histological/molecular pathology, diagnosed with GBM WHO grade 4
- According to the histopathology or radiological imaging, confirmed disease progression or recurrence
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- First recurrence after failure to the SOC therapy of newly diagnosed disease-Stupp regimen (which was surgery + standard RT + concurrent TMZ and adjuvant TMZ), or first recurrence after failure to the SOC therapy of newly diagnosed disease-Stupp regimen (which was surgery + standard RT + concurrent TMZ and adjuvant TMZ) and received Bevacizumab treatment
- Participants with either unresectable lesions, or with resectable lesions who have undergone prior surgical resection, or with resectable lesions and no planned reoperation within 3 months after enrollment based on Investigator's judgment
- Participants voluntarily provide the latest archival tumor or fresh biopsies FFPE samples (at least 8 consecutive non-stained sections) for B7H3 expression test by Immunohistochemistry (IHC), and the clinical pathology confirms positive B7H3 expression, defined as the proportion of 2+ and 3+ ≥ 20% (Reference refer to Appendix 13.1) or historical B7H3 positive expression within 12 months at the time of enrollment
- Karnofsky Performance Status (KPS) score ≥ 60
- Life expectancy of ≥ 12 weeks
- Adequate organ and marrow functions as defined below: (blood transfusion, blood component transfusion, or hematopoietic stimulating factors within 7 days prior to the first dose is not allowed)
- Hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, and hemoglobin ≥ 90 g/L
- Hepatic: ALT and AST ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN
- Renal: Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated Cr clearance ≥ 30.0 mL/min using Cockcroft-Gault formula
- Coagulation: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (participant is receiving anticoagulant therapy in which case the APTT and INR must be within the therapeutic range of intended use for the anticoagulant)
- Cardiac: Left ventricular ejection fraction (LVEF) > 50%
- Oxygen saturation ≥ 95% on room air
- Has adequate treatment washout period before IP treatment, defined as:
- Major surgery : ≥ 2 weeks§; Ommaya reservoir placement surgery was excluded Radiation therapy : ≥ 12 weeks (unless the progression is clearly outside the radiation field (e.g., beyond the high-dose region or 80% isodose line) or there is pathologic confirmation of disease progression) Chemotherapy :≥ 23 days for TMZ ; ≥ 6 weeks for Nitrosoureas or Mitomycin C (such as: Carmustine, Lomustine and so on) Biologic agents (such as: PD1/PD-L1 antibodies) : ≥ 4 weeks Small molecule targeted drugs (TKIs such as Regorafenib and Anlotinib) : ≥ 3 weeks or 5 half-lives (including toxic metabolites), whichever is longer Other antitumor therapies :≥ 4 weeks
- §Any surgery incisions or wounds must be completely healed
- Not including Bevacizumab
- Intracranial hemorrhage Grade ≤ 1 (per NCI-CTCAE v5.0), and toxicity from previous systemic treatment returns to ≤ Grade 1 or baseline before the first CAR-T dose (except alopecia)
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of the pre-study visit, through the course of the study and for 120 days after the last dose of study medication
- Female patients of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication
- Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year
- Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
Who cannot join
- A patient meeting any of the following criteria is not eligible to participate in this study (applied to all patients screened in safety run-in and dose expansion stages, unless specified):
- Brainstem and thalamus recurrence, spinal cord dissemination or extracranial metastasis
- The largest diameter of a single tumor lesion > 5 cm, or the sum of the largest diameters of multiple lesions > 6 cm
- Symptoms and signs of chronic intracranial hypertension that are difficult to control with drugs (such as daily use of Mannitol > 500 mL or Dexamethasone > 15 mg or Methylprednisolone > 80 mg or other hormones at the same dose)
- Uncontrolled seizure or epilepsy aggravation requiring escalation of antiepileptic therapy over the last 4 weeks
- Participated in other therapeutic clinical trials within 4 weeks prior to screening
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- Previously received other allogeneic tissue/solid organ transplantation OR other CAR-T cell therapy
- Previously received Carmustine wafer, oncolytic viruses or other intratumoral implants treatment (e.g., GLIADEL® Wafer)
- Prior history of severe allergy to any component or biological product of the investigational drug
- History of other malignancy within 5 years of screening with the following exceptions: a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, c) carcinoma in situ of the breast, d) local prostate cancer after radical resection and/ or definitive RT with stable prostate specific antigen (PSA) levels for 1 year
- Serious diseases such as active systemic infection, coagulation dysfunction, history of interstitial lung disease, radiation pneumonitis, or evidence of active pneumonia that is not considered appropriate by Investigator
- Clinically significant uncontrolled heart, lung, liver, renal and neuro insufficiency including Class III or above heart failure according to the New York Heart Association (NYHA) standard, Stage IV liver cirrhosis; chronic kidney disease (CKD) Stage III or above; Symptoms of severe respiratory failure involving other organs; Uncontrolled seizure activity and/or clinically evident progressive encephalopathy
- History or active autoimmune diseases. However, participants with type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disease that do not require systemic treatment (vitiligo, psoriasis, or hair loss) may be allowed. For any uncertainty, it is recommended to consult the sponsor's medical monitor before signing the informed consent
- Received live vaccines within 2 weeks before the first IP treatment or plans to receive live vaccines during the study period
- Participants with a history of active pulmonary tuberculosis infection within 1 year, those participants with history more than 1 year prior to the first dose of IP may be considered suitable if there is no evidence of active pulmonary tuberculosis judged by Investigator
- Active hepatitis B virus infection or hepatitis C virus infection (defined as HCV-IgM antibody positive, if HCV-RNA is lower than the lower limit of detection, enrollment is allowed); Or human immunodeficiency virus (HIV) infection (defined as HIV antibody positive); Or positive in Treponema pallidum antibody test
- According to Investigator's judgment, the participant suffers from severe neurocognitive impairment
- Unable to safely undergo ICV injection related procedures
- Any disease that currently needs systemic steroid treatment
- Unavailable for the follow-up assessment or concern for participant's compliance with the protocol procedures
- Presence of any conditions that could, in the opinion of Investigator, compromise the participant's ability to participate in the study
- Subjects who are lactating -
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Taiwan3 sites
Hualien Tzu Chi Hospital
Hualien City, 970473
Shinn-Zong Lin, MD, PhD, 0000000000
Shinn-Zong Lin, MD, PhD
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, 833401
Fu-Yuan Shih, MD, 000-000-0000 ext. 0000
Fu-Yuan Shih, MD
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333423
Kuo-Chen Wei, MD, 0000000000 ext. 0000
Kuo-Chen Wei, MD
United States1 site
The Johns Hopkins Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Solmaz Sahebjam, MD, 000-000-0000
Solmaz Sahebjam, MD
About this study
Official title: A Phase II, Open-Label, Multicenter Study With a Safety Run-In to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of MT027 Administrated Intracerebroventricularly in Patients With Recurrent or Progressive Glioblastoma (WHO Grade 4)
This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.
Each participant will undergo screening, treatment (receiving MT027 at a dose of 3×10^7 cells), safety follow-up, and long-term follow-up periods.
MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle. If the participant does not experience any unacceptable toxicities and disease progress in the first cycle, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.
Read the detailed description
This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.
The study will begin with a safety run-in of 3 to 6 participants to evaluate the safety and tolerability of MT027 at a dose of 3×10^7 cells. Once the DLT assessment is complete, an additional 34 participants will be enrolled, bringing the total to 40, to evaluate the treatment's efficacy. Each participant will undergo screening, treatment, safety follow-up, and long-term follow-up periods. Any participant who has discontinued from study treatment other than disease progression will also continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, withdrawal from the study, or death, whichever comes first. Upon completion of the safety follow-up, all patients, except those who died, withdrew consent, or were lost to follow-up, will enter to the long-term follow-up. It is regarded as the end of the study when the last participant has completed the 1-year long-term follow-up, or all participants have progressed, died, or lost to follow-up, whichever comes first. MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle, and the DLT observation period will be 28 days following the first dose of the first cycle (only for safety run-in group). After the DLT observation period, if the participant does not experience any unacceptable toxicities and disease progress, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. When confirming disease progression, the study treatment may still be continued if there's a potential for benefit, based on PI's discretion and the participant's willingness, particularly when there are no better treatment options available. Investigational product (IP) may be temporarily interrupted to allow safety management and will resume the study treatment dose after participant's adverse events are recovered to the Grade 1 level or baseline, per PI's discretion. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.
- Being tested
- Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3
- Keywords
- Recurrent or Progressive Glioblastoma, MT027
- Medical subject headings
- Recurrence
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: From the first dose to 2 weeks after the second dose
12-month overall survival (OS) rate
Measured: From the first dose to 12 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start30 Nov 2026 (estimated)
- Primary completion13 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeStudies 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)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386002
- Sponsor's protocol ID
- MT027-GBM-101
- Acronym
- GLIOMAX-101
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 14 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Study With a Safety Run-In to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of MT027 Administrated Intracerebroventricularly in Patients With Recurrent or Progressive Glioblastoma (WHO Grade 4)
- ClinicalTrials.gov ID
- NCT07386002
- Acronym / sponsor ID
- GLIOMAX-101 / MT027-GBM-101
- Keywords
- Recurrent or Progressive Glioblastoma, MT027
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- T-MAXIMUM Pharmaceutical IncIndustry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 13 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 4 Feb 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 Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.
Each participant will undergo screening, treatment (receiving MT027 at a dose of 3×10^7 cells), safety follow-up, and long-term follow-up periods.
MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle. If the participant does not experience any unacceptable toxicities and disease progress in the first cycle, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.
Detailed description
This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.
The study will begin with a safety run-in of 3 to 6 participants to evaluate the safety and tolerability of MT027 at a dose of 3×10^7 cells. Once the DLT assessment is complete, an additional 34 participants will be enrolled, bringing the total to 40, to evaluate the treatment's efficacy. Each participant will undergo screening, treatment, safety follow-up, and long-term follow-up periods. Any participant who has discontinued from study treatment other than disease progression will also continue to have tumor assessments until disease progression, initiation of subsequent anticancer therapies, withdrawal from the study, or death, whichever comes first. Upon completion of the safety follow-up, all patients, except those who died, withdrew consent, or were lost to follow-up, will enter to the long-term follow-up. It is regarded as the end of the study when the last participant has completed the 1-year long-term follow-up, or all participants have progressed, died, or lost to follow-up, whichever comes first. MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle, and the DLT observation period will be 28 days following the first dose of the first cycle (only for safety run-in group). After the DLT observation period, if the participant does not experience any unacceptable toxicities and disease progress, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. When confirming disease progression, the study treatment may still be continued if there's a potential for benefit, based on PI's discretion and the participant's willingness, particularly when there are no better treatment options available. Investigational product (IP) may be temporarily interrupted to allow safety management and will resume the study treatment dose after participant's adverse events are recovered to the Grade 1 level or baseline, per PI's discretion. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.
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 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Patients must meet all the following inclusion criteria to be enrolled in the study (applied to all patients screened in safety run-in and dose expansion stage, unless specified):
- Major surgery : ≥ 2 weeks§; Ommaya reservoir placement surgery was excluded Radiation therapy : ≥ 12 weeks (unless the progression is clearly outside the radiation field (e.g., beyond the high-dose region or 80% isodose line) or there is pathologic confirmation of disease progression) Chemotherapy :≥ 23 days for TMZ ; ≥ 6 weeks for Nitrosoureas or Mitomycin C (such as: Carmustine, Lomustine and so on) Biologic agents (such as: PD1/PD-L1 antibodies) : ≥ 4 weeks Small molecule targeted drugs (TKIs such as Regorafenib and Anlotinib) : ≥ 3 weeks or 5 half-lives (including toxic metabolites), whichever is longer Other antitumor therapies :≥ 4 weeks
- §Any surgery incisions or wounds must be completely healed
- Not including Bevacizumab
Key exclusion criteria (22 listed)
- A patient meeting any of the following criteria is not eligible to participate in this study (applied to all patients screened in safety run-in and dose expansion stages, unless specified):
- Brainstem and thalamus recurrence, spinal cord dissemination or extracranial metastasis
- The largest diameter of a single tumor lesion > 5 cm, or the sum of the largest diameters of multiple lesions > 6 cm
- Symptoms and signs of chronic intracranial hypertension that are difficult to control with drugs (such as daily use of Mannitol > 500 mL or Dexamethasone > 15 mg or Methylprednisolone > 80 mg or other hormones at the same dose)
- Uncontrolled seizure or epilepsy aggravation requiring escalation of antiepileptic therapy over the last 4 weeks
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: From the first dose to 2 weeks after the second dose
Incidence rate of Dose-limiting toxicity (DLT) after treatment in the safety run-in stage
12-month overall survival (OS) rate
Time frame: From the first dose to 12 months after the treatment
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 14 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.
4 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 Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by T-MAXIMUM Pharmaceutical Inc at 4 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 27 inclusion and 22 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 14 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 4 sites in Taiwan, United States. 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, MD (0000000000, 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: From the first dose to 2 weeks after the second dose). 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 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.