Adult Anaplastic AstrocytomaPhase 1NCT02015819
Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas
A Phase 1 study testing E. coli CD-expressing genetically modified neural stem cells, flucytosine and leucovorin calcium in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Oligodendroglioma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and determines the best dose of genetically modified neural stem cells and flucytosine when given together with leucovorin for treating patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma
- What is being tested?
- E. coli CD-expressing genetically modified neural stem cells, flucytosine and leucovorin calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2014to 7 Oct 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient has had a prior, histologically-confirmed, diagnosis of a grade III or IV glioma (including glioblastoma, anaplastic oligodendroglioma, or anaplastic astrocytoma, gliosarcoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma), or has a prior, histologically-confirmed, diagnosis of a grade II glioma and now has radiographic findings consistent with a high-grade glioma (grade III or IV)
- Imaging studies show evidence of recurrent, supratentorial tumor(s). The presence of infratentorial tumor is allowed as long as the patient also has supratentorial disease that is amenable to resection or biopsy.
- Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
- Patient has a Karnofsky performance status of >= 70%
- Patient has a life expectancy of >= 3 months
- Female patients of childbearing potential and sexually-active male patients must agree to use an effective method of contraception while participating in this study; women of childbearing potential must have a negative pregnancy test =< 2 weeks prior to registration
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- The patient must be in need of a craniotomy for tumor resection or a stereotactic brain biopsy for the purpose of diagnosis or differentiating between tumor progression versus treatment-induced effects following radiation therapy +/- chemotherapy
- Based on the neurosurgeon's judgement, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles
- Absolute neutrophil count (ANC) >= 1500 cells/mm^3
- Platelet count >= 100,000 cells/mm^3
- Total bilirubin =< 2.0 mg/dl
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 4 times the institutional upper limit of normal
- Serum creatinine =< the institutional upper limit of normal
- There is no limit to the number of prior therapies
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patient has anti-human leukocyte antigen (HLA) antibodies specific for HLA antigens expressed by the NSCs
- Patient has not recovered from any toxicity of prior therapies; an interval of
- At least 6 weeks must have elapsed since taking a nitrosourea-containing chemotherapy regimen
- At least 4 weeks since completing a non-nitrosourea-containing cytotoxic chemotherapy regimen (except temozolomide: only an interval of 23 days is required from the last dose administered when patient has been recently treated with the standard temozolomide regimen of daily for 5 days, repeated every 28 days)
- At least 2 weeks from taking the last dose of targeted agent
- At least 4 weeks from the last dose of bevacizumab
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- Patient is unable to undergo a magnetic resonance imaging (MRI)
- Patient is allergic to 5-FC, leucovorin, or 5-FU
- Patient has chronic or active viral infections of the central nervous system (CNS)
- Patient has a coagulopathy or bleeding disorder
- Patient has an uncontrolled illness including ongoing or active infection
- Patient is receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
- Patient has had prior therapy with neural stem cells
- Patient is pregnant or breast feeding; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is participating in this study
- Patient has another active malignancy
- Non-compliance; a patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Phase I Study of Cytosine Deaminase-Expressing Neural Stem Cells in Combination With Oral 5-Fluorocytosine and Leucovorin for the Treatment of Recurrent High-Grade Gliomas
This phase I trial studies the side effects and determines the best dose of genetically modified neural stem cells and flucytosine when given together with leucovorin for treating patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in the brain. The neural stem cells that are being used in this study were genetically modified express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine (5-FC) into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more tumor cells. The CD-expressing neural stem cells are administered directly into the brain. After giving the neural stem cells a few days to spread out and migrate to tumor cells, research participants take a 7 day course of oral 5-FC. (Depending on when a research participant enters the study, they may also be given leucovorin to take with the 5-FC.) When the 5-FC crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out of the neural stem cells to preferentially kill rapidly dividing tumor cells while minimizing toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery, will be used to administer additional doses of NSCs every two weeks, followed each time by a 7 day course of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer strategy may be an effective treatment for high-grade gliomas.
Funding Source - FDA OOPD
Read the detailed description
PRIMARY OBJECTIVES:
- To define the phase II recommended dose of intracerebrally administered cytosine deaminase (CD)-expressing neural stem cells (NSCs) in combination with oral 5-fluorocytosine (FC) (flucytosine) and leucovorin.
II. To determine the feasibility of treating study patients with more than 1 dose of NSCs followed by 7-day courses of 5-FC and leucovorin.
SECONDARY OBJECTIVES:
- To assess for possible development of NSC immunogenicity (anti-NSC T cell and/or antibody response) with repeat doses of NSCs.
II. To characterize the relationship between intracerebral and systemic concentrations of 5-FC and 5-FU at the maximum tolerated dose/maximum feasible dose level.
III. To describe the clinical benefit (defined as stable disease, partial response, or complete response) of this treatment regimen.
IV. To determine, at time of autopsy, the fate of the NSCs.
OUTLINE: This is dose-escalation study of CD-expressing genetically modified neural stem cells and flucytosine.
Patients receive CD-expressing neural stem cells intracranially (IC) on days 1 and 15 and flucytosine orally (PO) every 6 hours on days 4-10 and 18-24. Depending on when a subject enters the study, they may also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, 3 months, 6 months, 1 year, and then annually thereafter.
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Being tested
- E. coli CD-expressing genetically modified neural stem cells, flucytosine, leucovorin calcium, pharmacological study, laboratory biomarker analysis
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli CD-expressing genetically modified neural stem cellsBiological
Also called HB1.F3.CD neural stem cells
Given intracranially
flucytosineDrug
Also called 5-FC, 5-fluorocytosine, Ro 2-9915
Given orally
Also called CF, CFR, LV
Given orally
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (neural stem cells, flucytosine, leucovorin) | Experimental | Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Depending on when a subject enters the study, they may also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Dose escalation used the following dose levels:
Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg)
Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg)
Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg)
Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis Receives: Biological: E. coli CD-expressing genetically modified neural stem cells; Drug: flucytosine; Drug: leucovorin calcium; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD)
Number of DLTs per dose level and the MTD/MFD.
Measured: Day 28 of course 1
Number of Participants With Mechanical Issues With Repeat Administrations of NSCs Via Rickham
Number of participants with mechanical issues with repeat administrations of NSCs via Rickham.
Measured: 28 days after last infusion of NSCs, up to 6 months total
Secondary outcomes (5)
Number of Participants Developing Antibodies Against NSCs
Development of a antibody response to the NSCs will be evaluated by flow cytometry. Data from assessing for possible development of NSC immunogenicity with repeat exposure will be presented in an exploratory fashion using descriptive statistics.
Measured: While receiving treatment, up to 6 months.
Average Steady State Levels of 5-FC and 5-FU in the Brain
Pharmacokinetic (PK) data from the patients who undergo intracerebral microdialysis (dose level 4) will be summarized using descriptive statistics. All summaries will be exploratory in spirit.
Measured: Following the first dose of 5-FC, samples were collected every hour for 24 hours and then every 3 hours thereafter until the end of the 7-day course of 5-FC or until the microdialysis catheter stopped functioning.
Average Steady State Levels of 5-FC Concentrations in Plasma
PK data from the patients who undergo intracerebral microdialysis (dose level 4) will be summarized using descriptive statistics.
Measured: Samples were obtained prior to the first dose of 5-FC then every 30 minutes for 3 hours, additional samples at 4 and 6 hours after the morning doses on days 4, 5. On days 6, 7, 8 blood samples were collected just before morning dose and 90 minutes later
Comparison of 5-FC in the Brain to 5-FC in the Plasma
PK data from the patients who undergo intracerebral microdialysis (dose level 4) will be summarized using the mean ratio of average brain interstitial 5-FC concentrations to the average steady-state plasma levels.
Measured: The ratio of average brain interstitial 5-FC and 5-FU concentrations to average plasma steady-state levels was calculated using all measured data.
Summary of Tumor Response Using the Response Assessment in Neuro-Oncology (RANO) Criteria
Per RANO criteria:
Complete Response (CR): Complete disappearance of all enhancing disease that is sustained for at least 4 weeks, stable or improved non-enhancing FLAIR/T2 lesions, no new lesions, off corticosteroids, and neurologically stable or improved.
Partial Response (PR): >= 50% decrease of all measurable enhancing lesions, sustained or at least 4 weeks, no progression of non-measurable disease, stable or improved non-enhancing FLAIR/T2 lesions, non new lesions, corticosteroid dose stable or reduced, and neurologically stable or improved.
Stable Disease (SD): Dose not qualify for CR, PR, or PD, stable non-enhancing FLAIR/T2 lesions, stable or reduced corticosteroids, clinically stable.
Progressive Disease (PD): >=25% increase in enhancing lesion despite stable or increasing steroid dose, increase (significant) in non-enhancing T2/FLAIR lesions that is not attributable to other non-tumor causes, any new lesions, clinical deterioration
Measured: Up to 3 years post NSC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start28 Oct 2014
- Primary completion7 Oct 2017
- Study completion7 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Anaplastic AstrocytomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jana Portnow, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015819
- Sponsor's protocol ID
- 13401
- Other IDs
- NCI-2013-02346, 13401, FD-R-004816
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2013
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Cytosine Deaminase-Expressing Neural Stem Cells in Combination With Oral 5-Fluorocytosine and Leucovorin for the Treatment of Recurrent High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT02015819
- Acronym / sponsor ID
- 13401
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Oct 2014 (actual)
- Primary completion
- 7 Oct 2017 (actual)
- Study completion
- 7 Oct 2017 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 29 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial studies the side effects and determines the best dose of genetically modified neural stem cells and flucytosine when given together with leucovorin for treating patients with recurrent high-grade gliomas. Neural stem cells can travel to sites of tumor in the brain. The neural stem cells that are being used in this study were genetically modified express the enzyme cytosine deaminase (CD), which converts the prodrug flucytosine (5-FC) into the chemotherapy agent 5-fluorouracil (5-FU). Leucovorin may help 5-FU kill more tumor cells. The CD-expressing neural stem cells are administered directly into the brain. After giving the neural stem cells a few days to spread out and migrate to tumor cells, research participants take a 7 day course of oral 5-FC. (Depending on when a research participant enters the study, they may also be given leucovorin to take with the 5-FC.) When the 5-FC crosses into brain, the neural stem cells convert it into 5-FU, which diffuses out of the neural stem cells to preferentially kill rapidly dividing tumor cells while minimizing toxicity to healthy tissues. A Rickham catheter, placed at the time of surgery, will be used to administer additional doses of NSCs every two weeks, followed each time by a 7 day course of oral 5-FC (and possibly leucovorin). This neural stem cell-based anti-cancer strategy may be an effective treatment for high-grade gliomas.
Funding Source - FDA OOPD
Detailed description
PRIMARY OBJECTIVES:
- To define the phase II recommended dose of intracerebrally administered cytosine deaminase (CD)-expressing neural stem cells (NSCs) in combination with oral 5-fluorocytosine (FC) (flucytosine) and leucovorin.
II. To determine the feasibility of treating study patients with more than 1 dose of NSCs followed by 7-day courses of 5-FC and leucovorin.
SECONDARY OBJECTIVES:
- To assess for possible development of NSC immunogenicity (anti-NSC T cell and/or antibody response) with repeat doses of NSCs.
II. To characterize the relationship between intracerebral and systemic concentrations of 5-FC and 5-FU at the maximum tolerated dose/maximum feasible dose level.
III. To describe the clinical benefit (defined as stable disease, partial response, or complete response) of this treatment regimen.
IV. To determine, at time of autopsy, the fate of the NSCs.
OUTLINE: This is dose-escalation study of CD-expressing genetically modified neural stem cells and flucytosine.
Patients receive CD-expressing neural stem cells intracranially (IC) on days 1 and 15 and flucytosine orally (PO) every 6 hours on days 4-10 and 18-24. Depending on when a subject enters the study, they may also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days, 3 months, 6 months, 1 year, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (neural stem cells, flucytosine, leucovorin) | Experimental | Biological: E. coli CD-expressing genetically modified neural stem cells, Drug: flucytosine, Drug: leucovorin calcium, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Depending on when a subject enters the study, they may also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation used the following dose levels: Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg) Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg) Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient has had a prior, histologically-confirmed, diagnosis of a grade III or IV glioma (including glioblastoma, anaplastic oligodendroglioma, or anaplastic astrocytoma, gliosarcoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma), or has a prior, histologically-confirmed, diagnosis of a grade II glioma and now has radiographic findings consistent with a high-grade glioma (grade III or IV)
- Imaging studies show evidence of recurrent, supratentorial tumor(s). The presence of infratentorial tumor is allowed as long as the patient also has supratentorial disease that is amenable to resection or biopsy.
- Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide
- Patient has a Karnofsky performance status of >= 70%
- Patient has a life expectancy of >= 3 months
Key exclusion criteria (16 listed)
- Patient has anti-human leukocyte antigen (HLA) antibodies specific for HLA antigens expressed by the NSCs
- Patient has not recovered from any toxicity of prior therapies; an interval of
- Patient is unable to undergo a magnetic resonance imaging (MRI)
- Patient is allergic to 5-FC, leucovorin, or 5-FU
- Patient has chronic or active viral infections of the central nervous system (CNS)
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 |
|---|---|---|
| E. coli CD-expressing genetically modified neural stem cellsAlso: HB1.F3.CD neural stem cellsGiven intracranially | Biological | Treatment (neural stem cells, flucytosine, leucovorin) |
| flucytosineAlso: 5-FC, 5-fluorocytosine, Ro 2-9915Given orally | Drug | Treatment (neural stem cells, flucytosine, leucovorin) |
| leucovorin calciumAlso: CF, CFR, LVGiven orally | Drug | Treatment (neural stem cells, flucytosine, leucovorin) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (neural stem cells, flucytosine, leucovorin) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (neural stem cells, flucytosine, leucovorin) |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD)
Time frame: Day 28 of course 1
Number of DLTs per dose level and the MTD/MFD.
Number of Participants With Mechanical Issues With Repeat Administrations of NSCs Via Rickham
Time frame: 28 days after last infusion of NSCs, up to 6 months total
Number of participants with mechanical issues with repeat administrations of NSCs via Rickham.
5 secondary outcomes
Number of Participants Developing Antibodies Against NSCs
Time frame: While receiving treatment, up to 6 months.
Average Steady State Levels of 5-FC and 5-FU in the Brain
Time frame: Following the first dose of 5-FC, samples were collected every hour for 24 hours and then every 3 hours thereafter until the end of the 7-day course of 5-FC or until the microdialysis catheter stopped functioning.
Average Steady State Levels of 5-FC Concentrations in Plasma
Time frame: Samples were obtained prior to the first dose of 5-FC then every 30 minutes for 3 hours, additional samples at 4 and 6 hours after the morning doses on days 4, 5. On days 6, 7, 8 blood samples were collected just before morning dose and 90 minutes later
Comparison of 5-FC in the Brain to 5-FC in the Plasma
Time frame: The ratio of average brain interstitial 5-FC and 5-FU concentrations to average plasma steady-state levels was calculated using all measured data.
Summary of Tumor Response Using the Response Assessment in Neuro-Oncology (RANO) Criteria
Time frame: Up to 3 years post NSC infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Jana Portnow principal investigator
City of Hope Medical Center
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 E. coli CD-expressing genetically modified neural stem cells, flucytosine and leucovorin calcium in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Oligodendroglioma, run by City of Hope Medical Center 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 15 inclusion and 16 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: finished, as of the sponsor's last update on 3 Nov 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 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?
Yes. Results are posted in the registry (first posted 29 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD) (time frame: Day 28 of course 1). 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 3 Nov 2026.