GlioblastomaPhase 1/2NCT05664243

A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma

A Phase 1/2 study testing Autologous genetically modified gamma-delta T cells and Allogeneic genetically modified gamma-delta T cells in people with Glioblastoma, run by In8bio Inc. at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This multicenter, Phase 1b/2 study is being conducted to determine if the experimental cell therapy is safe, tolerable and can delay the return of cancer in patients with a newly diagnosed or recurrent glioblastoma multiforme (GBM) in combination with standard chemotherapy treatment temozolomide (TMZ). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma
What is being tested?: Autologous genetically modified gamma-delta T cells and Allogeneic genetically modified gamma-delta T cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 5 sitesUnited States
Study dates: 8 Sep 2023to Dec 2026
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with histologically or cytologically confirmed history of IDH-wild type glioblastoma
Phase 1b and Arm B of Phase 2: Subjects must have completed no more than one standard therapy for glioblastoma, have received no prior Avastin® therapy (unless solely used for edema management) and be eligible for resection
Arms A and C: Subjects must have newly diagnosed, treatment naïve glioblastoma
Phase 1b and Arm B and Arm C: Subjects must have a partially matched haploidentical or matched related donor.
Subjects with magnetic resonance imaging (MRI) features consistent with and suspicious for recurrent malignant glioma in Phase 1b and Arm B.
Agreeable to inserting and maintaining a Rickham catheter.

Show all 10Show fewer

≥ 18 years of age.
Karnofsky Performance Status ≥ 70%
Female subjects of childbearing potential must have a negative urine/serum pregnancy test within 72 hours of study enrollment. Female subjects of childbearing potential are those who have not been surgically sterilized or have not been free of menses for > 2 years.
Male subjects and their female partners and female subjects of childbearing potential must be willing to use a combination of two methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study.

Who cannot join

Subject in Arm A or donor from Phase 1b, Arms B, and Arm C received vaccinations within 4 weeks or underwent surgery (major or minor) within 72 hours before leukapheresis collection.
Cellular immunotherapy or gene therapy or within six weeks prior to entering the study, surgical resection or alkylating agent chemotherapy within four weeks prior to entering the study, receiving tumor treating fields (TTF) Optune therapy, or have received experimental immunotherapy at any time
Subjects receiving any other investigational agents concurrently while on study.
Have not recovered from adverse events (≤ Grade 1) from previously administered therapy. Subjects with alopecia unless of immune origin are an exception to this criterion and may qualify for this study
Have received prior treatment with an allogeneic therapy, including bone marrow or solid tumor transplant.
Concurrent malignancy or an active second malignancy. Subjects with a history of second malignancy must have no evidence of cancer for two years prior to enrolment or have a surgically cured cancer with low risk of recurrence to enroll. Discuss with medical monitor prior to enrolment.

Show all 11Show fewer

Contraindication to the placement of an intracranial access device (Rickham catheter) at the time of surgery.
Prior history of encephalitis, multiple sclerosis, or other CNS infection <1 year prior to glioblastoma diagnosis.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or any other medical condition that precludes surgery. Also, medical/surgical/psychiatric illness/social situations that would limit compliance with study requirements or confound interpretation of safety and efficacy data. Subjects with a history of seizure as a result of their glioblastoma must be seizure free and on appropriate anti-epileptic medication for 3 weeks prior to dosing with the investigational agent.
Allergies/hypersensitivity to amino bisphosphonates such as Zoledronate®, Pamidronate® or similar.
History of HIV or active hepatitis even if well controlled or history of an autoimmune condition.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Wexner Medical Center- James Cancer Center
Columbus, Ohio, 43210
University of Louisville Hospital/James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Moffitt Cancer Center
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1b / 2 Open-label Study to Investigate the Safety, Tolerance and Efficacy of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide (TMZ) in Subjects With Recurrent or Newly Diagnosed Glioblastoma

Read the detailed description

This is a Phase 1b and 2 open-label cellular therapy trial using genetically modified gamma-delta (γδ) T cells or DeltEx Drug Resistant Immunotherapy (DRI). Gamma-delta T cells are a type of immune cell that may help the immune system recognize and kill cancer cells. The cells have been modified to make them resistant to the killing effects of chemotherapy such that they may be administered in combination with chemotherapy without being destroyed. The chemotherapy that is being used in this study is called temozolomide (TMZ) which is the standard-of-care used to treat glioblastoma patients. The DRI cells are given in combination with a standard dose of TMZ and are administered through a catheter directly into the brain where the tumor is located.

There are four arms to this study for eligible subjects with either newly diagnosed or relapsed IDH wild-type (IDH-wt) glioblastoma (GBM). Arm A will enroll newly diagnosed glioblastoma subjects to receive DRI cells derived from their own cells (autologous). The Phase 1b, Arms B and C will enroll subjects to receive DRI cells derived from a donor's cells (allogeneic). Subjects in the Phase 1b portion and Arm B must have relapsed disease, that is disease that has returned after initial treatment, while Arm A and C subjects must have newly diagnosed disease.

Prescreening subjects will have a standard-of-care surgical resection of their tumor. Once their preliminary eligibility is confirmed, they will have a Rickham catheter placed which is a device typically used to deliver chemotherapy into the brain that will be used to deliver the DRI cells directly to the tumor.

Following the surgical resection, subjects in Arm A will return to the study doctor's office/clinic to undergo a procedure called an apheresis. This procedure will isolate the immune cells from the blood to help make the DRI product for the subject. These cells include the gamma-delta T cells that will be used to make the DRI cells. Once the cells for the DRI product are made, they are frozen and stored for future use. In the Phase Ib and Arms B and C of the trial, a donor will undergo apheresis to provide the source of cells for the DRI product.

Following apheresis and confirmation that the required number of gamma-delta T cells were successfully collected; subjects in Arm A and C will begin the recommended or standard-of-care treatment for newly diagnosed GBM. This will include six weeks of chemotherapy with TMZ and radiation. Subjects will then have about a four week break prior to beginning the maintenance phase of treatment. Maintenance therapy includes five days of chemotherapy, every 28 days, which is repeated for six cycles. The previously frozen DRI product is thawed, prepared and is infused on the first day of each five-day cycle through the Rickham catheter. Subjects received a total of 6 infusions.

Subjects in the Phase Ib and Arm B will only receive one dose of TMZ along with the DRI product every 28 days for a total of six cycles.

Subjects will be observed for a of minimum 30 days after receiving the first dose of the DRI gamma-delta T cells. Subjects will be followed for potential side effects. The approximate duration of the study may be up to 15 years, or until disease progression or subjects withdraw from the study.

Conditions: Glioblastoma
Being tested: Autologous genetically modified gamma-delta T cells, Allogeneic genetically modified gamma-delta T cells
Keywords: Glioblastoma, Brain Neoplasms, Glioma, Neoplasms, Neuroepithelial, Central Nervous System Neoplasms, Neoplasms by Site
Medical subject headings: Glioblastoma, Brain Neoplasms, Glioma, Neoplasms, Central Nervous System Neoplasms, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous genetically modified gamma-delta T cellsBiological
Arm A: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance
Allogeneic genetically modified gamma-delta T cellsBiological
Phase 1b and Arm B: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with D1 of TMZ 150mg/m2
Arms C: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance

Study groups in NCT05664243
Study group	Role	What they receive
1) Autologous Newly Diagnosed Disease: Phase 2 Arm A	Experimental	Arm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide. Receives: Biological: Autologous genetically modified gamma-delta T cells
2) Allogeneic Relapsed Disease: Phase 1b and Phase 2	Experimental	Phase 1b subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide Receives: Biological: Allogeneic genetically modified gamma-delta T cells
3) Allogeneic Newly Diagnosed Disease: Phase 2 Arm C	Experimental	Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.

What is being measured

The primary outcome is the main question the study is designed to answer.

Autologous Phase 2, Arm A in newly diagnosed glioblastoma: 12-month overall survival (OS) rate
Date of first dose to date of death by any cause
Measured: 12 Months
Allogeneic Phase 1b, establishes the recommended phase 2 dose (RP2D) for phase 2 allogeneic arms and subject or product characteristics that will optimize manufacturing
<30% dose limiting toxicity (DLT) observed with dose
Measured: 28 days
Allogeneic Phase 2, Arm B confirmed recurrent glioblastoma, 9-month overall survival (OS)
Date of first dose to date of death by any cause
Measured: 9 Months
Allogeneic Phase 2, Arm C newly diagnosed glioblastoma, 12-month overall survival (OS) rate
Date of first dose to date of death by any cause
Measured: 12 Months

Secondary outcomes (6)

Assessment of safety
Assessment of safety is based on total number of treatment emergent adverse events and serious adverse events Assessment of safety is also based on change from baseline of clinical laboratory tests including change in liver function tests, renal function and complete blood counts Assessment of safety is also based on change from baseline of vital signs including heart rate, blood pressure, temperature and pulse oximetry
Measured: 12 Months
Assessment of tolerability
Assessment of tolerability is based on total number of treatment emergent adverse events and serious adverse events Assessment of tolerability is also based on change from baseline of clinical laboratory tests including change in liver function tests, renal function and complete blood counts Assessment of tolerability is also based on change from baseline of vital signs including heart rate, blood pressure, temperature and pulse oximetry
Measured: 12 Months
Overall response rate (ORR)
ORR is defined as the rate of the best overall response as complete response (CR) or partial response (PR).
Measured: 12 Months
Time to progression (TTP)
Time to progression will be defined as the time from first dose until objective tumor progression
Measured: 12 Months
Progression free survival (PFS)
PFS will be defined as the time from first dose until objective tumor progression or death, whichever comes first.
Measured: 12 Months
Definition of product characteristics
Product characteristics that predict for maximal success of product creation:
Age of donor ( <50 years of age, 51-65 years of age, >65 years of age), Total white blood cell count and individual immune cell count (neutrophils, T cells, gamma delta T cells) of the apheresis product, Time to infusion of manufactured product of apheresis material (1 month, 2months)
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 2023Dec 2026

First posted23 Dec 2022
Study start8 Sep 2023
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GlioblastomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: Arm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide. Phase 1b and Arm B subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.
Masking: None (open label)
Enrolment: 4 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05664243
Sponsor's protocol ID: INB-400
Status last verified: Mar 2026
First submitted: 9 Dec 2022
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Zhao Y, Dong P, He W, Zhang J, Chen H. gammadelta T cells: Major advances in basic and clinical research in tumor immunotherapy. Chin Med J (Engl). 2024 Jan 5;137(1):21-33. doi: 10.1097/CM9.0000000000002781. Epub 2023 Aug 18.
PubMed 37592858

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

All Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b / 2 Open-label Study to Investigate the Safety, Tolerance and Efficacy of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide (TMZ) in Subjects With Recurrent or Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT05664243
Acronym / sponsor ID: INB-400
Conditions: Glioblastoma
Keywords: Glioblastoma, Brain Neoplasms, Glioma, Neoplasms, Neuroepithelial, Central Nervous System Neoplasms, Neoplasms by Site
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 4 participants (estimated)
Lead sponsor: In8bio Inc.Industry (pharma, biotech, devices)
Study start: 8 Sep 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 23 Dec 2022 (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.

Detailed description

Subjects in the Phase Ib and Arm B will only receive one dose of TMZ along with the DRI product every 28 days for a total of six cycles.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3
Model description: Arm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide. Phase 1b and Arm B subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.

Arm	Type	Receives
1) Autologous Newly Diagnosed Disease: Phase 2 Arm A	Experimental	Biological: Autologous genetically modified gamma-delta T cellsArm A subjects with newly diagnosed disease will receive autologously derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.
2) Allogeneic Relapsed Disease: Phase 1b and Phase 2	Experimental	Biological: Allogeneic genetically modified gamma-delta T cellsPhase 1b subjects with relapsed disease will have allogeneic derived, genetically modified gamma-delta T cells administered with temozolomide
3) Allogeneic Newly Diagnosed Disease: Phase 2 Arm C	Experimental	–Arm C subjects with newly diagnosed disease will receive allogeneic derived, genetically modified gamma-delta T cells administered with maintenance temozolomide.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subjects with histologically or cytologically confirmed history of IDH-wild type glioblastoma
Subjects with magnetic resonance imaging (MRI) features consistent with and suspicious for recurrent malignant glioma in Phase 1b and Arm B.
Agreeable to inserting and maintaining a Rickham catheter.
≥ 18 years of age.
Karnofsky Performance Status ≥ 70%

Key exclusion criteria (11 listed)

Subject in Arm A or donor from Phase 1b, Arms B, and Arm C received vaccinations within 4 weeks or underwent surgery (major or minor) within 72 hours before leukapheresis collection.
Cellular immunotherapy or gene therapy or within six weeks prior to entering the study, surgical resection or alkylating agent chemotherapy within four weeks prior to entering the study, receiving tumor treating fields (TTF) Optune therapy, or have received experimental immunotherapy at any time
Subjects receiving any other investigational agents concurrently while on study.
Have not recovered from adverse events (≤ Grade 1) from previously administered therapy. Subjects with alopecia unless of immune origin are an exception to this criterion and may qualify for this study
Have received prior treatment with an allogeneic therapy, including bone marrow or solid tumor transplant.

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
Autologous genetically modified gamma-delta T cellsArm A: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance	Biological	1) Autologous Newly Diagnosed Disease: Phase 2 Arm A
Allogeneic genetically modified gamma-delta T cellsPhase 1b and Arm B: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with D1 of TMZ 150mg/m2 Arms C: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance	Biological	2) Allogeneic Relapsed Disease: Phase 1b and Phase 2

Primary outcome

Autologous Phase 2, Arm A in newly diagnosed glioblastoma: 12-month overall survival (OS) rate
Time frame: 12 Months
Date of first dose to date of death by any cause
Allogeneic Phase 1b, establishes the recommended phase 2 dose (RP2D) for phase 2 allogeneic arms and subject or product characteristics that will optimize manufacturing
Time frame: 28 days
<30% dose limiting toxicity (DLT) observed with dose
Allogeneic Phase 2, Arm B confirmed recurrent glioblastoma, 9-month overall survival (OS)
Time frame: 9 Months
Date of first dose to date of death by any cause
Allogeneic Phase 2, Arm C newly diagnosed glioblastoma, 12-month overall survival (OS) rate
Time frame: 12 Months
Date of first dose to date of death by any cause

6 secondary outcomes

Assessment of safety
Time frame: 12 Months
Assessment of tolerability
Time frame: 12 Months
Overall response rate (ORR)
Time frame: 12 Months
Time to progression (TTP)
Time frame: 12 Months
Progression free survival (PFS)
Time frame: 12 Months
Definition of product characteristics
Time frame: 12 Months

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 4 Nov 2026.
Derived from this study: PubMed 37592858Zhao Y, Dong P, He W, Zhang J, Chen H. gammadelta T cells: Major advances in basic and clinical research in tumor immunotherapy. Chin Med J (Engl). 2024 Jan 5;137(1):21-33. doi: 10.1097/CM9.0000000000002781. Epub 2023 Aug 18.
Individual participant dataSharing planned: Undecided

Related trials for Glioblastoma

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

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.

Louis B Nabors, MD principal investigator

University of Alabama at Birmingham

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 4 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 5 sites 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?

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?

Autologous Phase 2, Arm A in newly diagnosed glioblastoma: 12-month overall survival (OS) rate (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05664243, which also lists 1 linked publication.

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 4 Nov 2026.