Recurrent GlioblastomaPhase 1/2NCT07416188
Novel Indenoisoquinolone CMYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
A Phase 1/2 study testing LMP744 and Conventional Surgery or Biopsy in people with Recurrent Glioblastoma and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Recurrent Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Relapsed Cancer
- What is being tested?
- LMP744 and Conventional Surgery or Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 31 Dec 2032
- Phase
- Phase 1/2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must meet all the following inclusion criteria to be deemed eligible for this study:
- Participants >= 18 years of age
- Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist
- Karnofsky Performance Status (KPS) >60
- Willing to use effective birth control method
- --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.
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- Agreeable to undergo surgical intervention for brain biopsy and/or resection.
- Initial diagnostic biopsy under 03-N-0164 will be performed to confirm recurrent disease and obtain pre-treatment tissue.
- The surgical intervention may include stereotactic/needle biopsy, open biopsy, and/or resection, as determined by neurosurgical assessment. Only participants for whom gross total resection of tumor is not expected to be achievable will be included in the study.
- Willing and able to appoint a durable power of attorney
- Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant and/or nursing females
- --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and/or nursing females will be excluded from receiving drug
- Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and/or poorly controlled congestive heart failure)
- Social situations that would limit compliance with study requirements, such as chronic homelessness
- Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)
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- Additional malignancy diagnosed or requiring active treatment within 1 year of screening
- Unable to undergo an MRI scan of the brain
- Active autoimmune disease that requires systemic treatment within 2 years of screening
- Cardiac disease
- >=2 MIs
- >=2 coronary revascularization procedures
- Cardiac Troponin T or I >= 2x the institutional upper limit of normal at screening
- Ejection fraction <45% on screening echocardiogram
- Chronic hypokalemia (K<2.5 mmol/L)
- Human Immunodeficiency Virus (HIV)
- Known history of HIV
- Positive HIV 1/2 at screening.
- Active Hepatitis B or Hepatitis C infection at screening
- Active infection requiring systemic antibacterial, antiviral or antifungal therapy <7 days prior to initiation of study drug
- Recipient of autologous or allogeneic T cells
- Solid organ or tissue transplant recipients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
Surgical Neurology Branch, (301) 496-2921, snbrecruiting@nih.gov
About this study
Official title: Phase 1/Phase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
Background:
Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.
Read more
Objective:
To test LMP744 in people with glioblastoma.
Eligibility:
People aged 18 years or older with glioblastoma that returned after treatment.
Design:
Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.
Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a "port" under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.
LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.
Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.
Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.
Participants will continue to have telehealth visits every 3 months after they stop taking the drug.
Read the detailed description
Study Description:
Patients will undergo pathological confirmation of recurrent glioblastoma via stereotactic or open biopsy (Visit 1, Day 1) to obtain baseline reference tissue. Following confirmation of recurrent glioblastoma by histopathological tissue analysis by a pathologist, study participants with confirmed histopathologically recurrent glioblastoma will be readmitted (Visit 2, Day 1). Patients will receive an initial cycle of 190 mg/m^2/day LMP744 infused over 1 hour for 5 consecutive days (Visit 2, Days 1-5). Participants will then undergo surgical intervention for brain biopsy and/or resection, as clinically appropriate based on neurosurgical assessment within 7 calendar days of the 5th dose of LMP744, but no earlier than 24 hours after the 5th dose of LMP744 (Visit 2, between Days 6 and 12 inclusive). Tissue, CSF, and plasma will be collected during the post-treatment surgical intervention for molecular analysis. Patients will then be discharged from the hospital. Following a 3-8-week period of recuperation, study participants will then resume LMP744 (5 days on; 23 days off; up to 12 cycles) and be followed until death.
A comparative pharmacodynamic analysis will be conducted on the pre- and post-treatment tissue to evaluate the biological response to LMP744 and correlate pharmacodynamic changes with clinical outcomes.
Objectives:
Primary Objective:
-To evaluate objective response rate (ORR) in patients with recurrent glioblastoma treated with up to 12 cycles of LMP744.
Secondary Objectives:
- To evaluate progression-free survival in patients with recurrent glioblastoma treated with up to 12 cycles of LMP744 compared to historical controls.
- To evaluate overall survival (OS) in patients with recurrent glioblastoma treated with up to 12 cycles of LMP744 compared to historical controls.
- To assess the pharmacologic (PK/PD) response by exploring molecular and metabolic changes in pre- versus posttreatment glioblastoma tissue following administration of LMP744.
- To assess the impact of LMP744 treatment on self-reported quality of life (QOL) as measured by the validated SF-36 instrument.
Exploratory Objective:
- To explore the molecular changes observed in post-treatment tissue with clinical outcomes, aiming to identify potential predictive markers of response to LMP744.
- To explore changes in the molecular and metabolic profiles in matched tissue, CSF, and plasma from patients treated with LMP744 compared to their pre-treatment baseline.
Safety Outcomes:
To descriptively monitor, document, and report adverse events (AEs) and serious adverse events (SAEs) in participants with recurrent glioblastoma treated with LMP744.
Endpoints:
Primary Endpoint:
-Stable disease or Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria
Secondary Endpoints:
- PFS will be assessed based on the RANO 2.0 criteria for glioblastoma assessment as follows:
- Imaging Criteria:
- >=25% or more increase in enhancing lesions despite stable or increasing steroid dose
- >=25% increase in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes
- Occurrence of any new lesions
- Clinical Features:
- Clinical deterioration not attributable to other non-tumor causes or steroid decrease
- Overall survival in patients treated with LMP744
- Pharmacologic (PK/PD) response measured by molecular (transcriptomic, proteomic and/or metabolomic) tissue level changes and Differential molecular changes in tissues pre-versus post-LMP744 treatment
- Self-reported quality of life (QOL) as measured by the SF-36 survey at baseline, after each treatment cycle, and at study completion.
- Conditions
- Recurrent Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Relapsed Cancer, Recurrent Tumor, Glioblastoma Multiforme, Recurring Glioblastoma
- Being tested
- LMP744, Conventional Surgery or Biopsy
- Keywords
- Recurrent Glioblastoma, Glioma, Neoplasms, Neoplasms, Nerve Tissue, Neoplasms by Histological Type, Glioblastoma Multiforme (GBM), Phase I, Phase II, Brain Cancer
- Medical subject headings
- Glioblastoma, Recurrence, Central Nervous System Neoplasms, Glioma, Brain Neoplasms, Neoplasms, Neoplasms, Nerve Tissue, Neoplasms by Histologic Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMP744Drug
Indenoisoquinolone C-MYC/TOPOISOMERASE 1 Inhibitor
Conventional Surgery or BiopsyProcedure or surgery
Conventional Surgery or Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | All patients will receive LMP744 as the interventional drug along with surgery for a biopsy and a second surgery for either resection or an additional biopsy to compare the tissue pre vs. post-drug treatment. Receives: Drug: LMP744; Procedure: Conventional Surgery or Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria
As ORR is associated with survival experience, this endpoint allows for objective evaluation of efficacy of LMP744 in this proof-of-concept phase 2 trial
Measured: 5 years
Secondary outcomes (4)
Progression-Free Survival (PFS): Time from the start of treatment with LMP744 until disease progression based on RANO 2.0 criteria
PFS provides a measure of treatment efficacy in delaying tumor progression. While the study is not powered to demonstrate superiority of LMP744 to concurrent controls, the study will compare LMP744 to historical controls to generate information for planning of a future phase 3 trial.
Measured: 5 years
Overall Survival (OS): Time from the start of treatment with LMP744 until death from any cause
OS is the gold standard for assessing the ultimate benefit of a therapy on survival. We will compare OS between LMP744 and historical controls to provide information for planning of a future phase 3 trial
Measured: 5 years
Changes in transcriptomic and proteomic profiles before and after LMP744 treatment
Evaluating changes in these markers will provide insight into the pharmacodynamic effects of LMP744 at the molecular level. The selected markers are involved in DNA damage response, cell cycle regulation, and survival pathways, which are critical in understanding the tumor's response to the drug.
Measured: 5 years
Change in self-reported quality of life (QOL) as measured by the SF-36 survey at baseline, after each treatment cycle, and at study completion.
The SF-36 is a validated tool for assessing the quality of life in cancer patients and captures the broad impact of treatment on physical, emotional, and social well-being. Tracking changes in QOL over time will provide insight into the patient-reported outcomes related to LMP744 treatment. This endpoint is essential for understanding the broader implications of treatment beyond clinical and molecular measures, giving a more comprehensive assessment of treatment benefit or burden.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Jul 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sadhana Jackson, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416188
- Sponsor's protocol ID
- 10002185
- Other IDs
- 002185-N
- Status last verified
- 14 Oct 2026
- First submitted
- 14 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share IPD as requested by publications and CRADA partner.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/Phase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC/TOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07416188
- Acronym / sponsor ID
- 10002185
- Conditions
- Recurrent Glioblastoma, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Relapsed Cancer, Recurrent Tumor, Glioblastoma Multiforme, Recurring Glioblastoma
- Keywords
- Recurrent Glioblastoma, Glioma, Neoplasms, Neoplasms, Nerve Tissue, Neoplasms by Histological Type, Glioblastoma Multiforme (GBM), Phase I, Phase II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 18 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.
Background:
Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.
Objective:
To test LMP744 in people with glioblastoma.
Eligibility:
People aged 18 years or older with glioblastoma that returned after treatment.
Design:
Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.
Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a "port" under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.
LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.
Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.
Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.
Participants will continue to have telehealth visits every 3 months after they stop taking the drug.
Detailed description
Study Description:
Patients will undergo pathological confirmation of recurrent glioblastoma via stereotactic or open biopsy (Visit 1, Day 1) to obtain baseline reference tissue. Following confirmation of recurrent glioblastoma by histopathological tissue analysis by a pathologist, study participants with confirmed histopathologically recurrent glioblastoma will be readmitted (Visit 2, Day 1). Patients will receive an initial cycle of 190 mg/m^2/day LMP744 infused over 1 hour for 5 consecutive days (Visit 2, Days 1-5). Participants will then undergo surgical intervention for brain biopsy and/or resection, as clinically appropriate based on neurosurgical assessment within 7 calendar days of the 5th dose of LMP744, but no earlier than 24 hours after the 5th dose of LMP744 (Visit 2, between Days 6 and 12 inclusive). Tissue, CSF, and plasma will be collected during the post-treatment surgical intervention for molecular analysis. Patients will then be discharged from the hospital. Following a 3-8-week period of recuperation, study participants will then resume LMP744 (5 days on; 23 days off; up to 12 cycles) and be followed until death.
A comparative pharmacodynamic analysis will be conducted on the pre- and post-treatment tissue to evaluate the biological response to LMP744 and correlate pharmacodynamic changes with clinical outcomes.
Objectives:
Primary Objective:
-To evaluate objective response rate (ORR) in patients with recurrent glioblastoma treated with up to 12 cycles of LMP744.
Secondary Objectives:
- To evaluate progression-free survival in patients with recurrent glioblastoma treated with up to 12 cycles of LMP744 compared to historical controls.
- To evaluate overall survival (OS) in patients with recurrent glioblastoma treated with up to 12 cycles of LMP744 compared to historical controls.
- To assess the pharmacologic (PK/PD) response by exploring molecular and metabolic changes in pre- versus posttreatment glioblastoma tissue following administration of LMP744.
- To assess the impact of LMP744 treatment on self-reported quality of life (QOL) as measured by the validated SF-36 instrument.
Exploratory Objective:
- To explore the molecular changes observed in post-treatment tissue with clinical outcomes, aiming to identify potential predictive markers of response to LMP744.
- To explore changes in the molecular and metabolic profiles in matched tissue, CSF, and plasma from patients treated with LMP744 compared to their pre-treatment baseline.
Safety Outcomes:
To descriptively monitor, document, and report adverse events (AEs) and serious adverse events (SAEs) in participants with recurrent glioblastoma treated with LMP744.
Endpoints:
Primary Endpoint:
-Stable disease or Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria
Secondary Endpoints:
- PFS will be assessed based on the RANO 2.0 criteria for glioblastoma assessment as follows:
- Imaging Criteria:
- >=25% or more increase in enhancing lesions despite stable or increasing steroid dose
- >=25% increase in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes
- Occurrence of any new lesions
- Clinical Features:
- Clinical deterioration not attributable to other non-tumor causes or steroid decrease
- Overall survival in patients treated with LMP744
- Pharmacologic (PK/PD) response measured by molecular (transcriptomic, proteomic and/or metabolomic) tissue level changes and Differential molecular changes in tissues pre-versus post-LMP744 treatment
- Self-reported quality of life (QOL) as measured by the SF-36 survey at baseline, after each treatment cycle, and at study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: LMP744, Procedure: Conventional Surgery or BiopsyAll patients will receive LMP744 as the interventional drug along with surgery for a biopsy and a second surgery for either resection or an additional biopsy to compare the tissue pre vs. post-drug treatment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant must meet all the following inclusion criteria to be deemed eligible for this study:
- Participants >= 18 years of age
- Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist
- Karnofsky Performance Status (KPS) >60
- Willing to use effective birth control method
Key exclusion criteria (22 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant and/or nursing females
- --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and/or nursing females will be excluded from receiving drug
- Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and/or poorly controlled congestive heart failure)
- Social situations that would limit compliance with study requirements, such as chronic homelessness
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 |
|---|---|---|
| LMP744Indenoisoquinolone C-MYC/TOPOISOMERASE 1 Inhibitor | Drug | Arm A |
| Conventional Surgery or BiopsyConventional Surgery or Biopsy | Procedure or surgery | Arm A |
Primary outcome
Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria
Time frame: 5 years
As ORR is associated with survival experience, this endpoint allows for objective evaluation of efficacy of LMP744 in this proof-of-concept phase 2 trial
4 secondary outcomes
Progression-Free Survival (PFS): Time from the start of treatment with LMP744 until disease progression based on RANO 2.0 criteria
Time frame: 5 years
Overall Survival (OS): Time from the start of treatment with LMP744 until death from any cause
Time frame: 5 years
Changes in transcriptomic and proteomic profiles before and after LMP744 treatment
Time frame: 5 years
Change in self-reported quality of life (QOL) as measured by the SF-36 survey at baseline, after each treatment cycle, and at study completion.
Time frame: 5 years
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 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share IPD as requested by publications and CRADA partner.
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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.
Sadhana Jackson, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LMP744 and Conventional Surgery or Biopsy in people with Recurrent Glioblastoma and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 11 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: looking for participants now, as of the sponsor's last update on 16 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 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 combined 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.
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 Sadhana Jackson, M.D. ((301) 594-7037, sadhana.jackson@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial response (>=50% disease reduction) or complete response (100% disease reduction) based on RANO 2.0 criteria (time frame: 5 years). 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 16 Oct 2026.