Chronic Kidney Disease, Stage 4Phase 1NCT06741072

BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants

A Phase 1 study testing Biospecimen Collection, Dulbecco''s Phosphate-Buffered Saline and Peptide Vaccine in people with Chronic Kidney Disease, Stage 4 and Chronic Kidney Disease, Stage 5, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 5, EBV-Related Lymphoproliferative Disorder
What is being tested?: Biospecimen Collection, Dulbecco''s Phosphate-Buffered Saline and Peptide Vaccine
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 28 Jun 2026to 31 Dec 2027
Phase: Phase 1
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B*08:01
Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive
Subjects must be seronegative for HIV
Subjects must be seronegative for hepatitis B and C
Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits
Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal

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Platelets above the lower limit of normal (LLN)
Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator
Total creatine kinase (CK) laboratory values < 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University [OSU] laboratory) at baseline (screening \& pre-study visit) and considered not clinically significant by the investigator
Subjects must not be taking antiviral therapy
Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination
Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug/placebo (PBS) administration
Agree not to receive any other investigational drug while enrolled in this study
Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations
Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL/min); stage 5: renal failure (GFR less than 15 mL/min). Patients will qualify for ESRD / kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Who cannot join

Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion
History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)
History of immune suppression or autoimmune disorder
Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable
Pregnant or breastfeeding subjects
For patient enrollment on the second cohort, "patients awaiting SOT", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Timothy J. Voorhees, MD, 614-293-6947, Timothy.Voorhees@osumc.edu
Timothy J. Voorhees
Recruiting

Other trials in United States

About this study

Official title: A Phase 1B Double Blinded Randomized Trial Evaluating Safety, Tolerability, and Immune Response of OSU-2131 a BZLF1 Peptide Vaccine With Stimulon™ QS-21 Solution Adjuvant in Healthy Volunteers and Patients Awaiting Solid Organ Transplantation

This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.

Read the detailed description

PRIMARY OBJECTIVE:

Determine the overall safety profile of three different dose levels of OSU-2131 vaccination each with 50 mcg Stimulon (Trademark) Quillaja saponin (QS)-21 Solution adjuvant (QS-21), wherein the OSU-2131 doses are 80, 240 and 480 mcg in healthy volunteers and similar safety profile of the identified maximum tolerated dose (MTD) in patients awaiting solid organ transplantation.

SECONDARY OBJECTIVES:

Determine the optimal immunologic dose (OID) to OSU-2131 vaccination (with QS-21) in all dose cohorts of 80, 240, and 480 mcg OSU-2131 (healthy volunteers) and, upon completing safety assessment, patients awaiting solid organ transplant (PASOT).

II. To perform laboratory correlative studies to examine immune responses to the OSU-2131 vaccine with the intent to communicate the research results and to generate a de-identified data set that can then be used for future comparisons with immune response data generated in future vaccine trials.

OUTLINE: This is a dose-escalation study of OSU-2131 with fixed-dose QS-21 followed by a dose-expansion study. Healthy volunteers are randomized to 1 of 2 groups. Patients awaiting a solid organ transplant are assigned to Group I.

GROUP I (OSU-2131 WITH QS-21): Healthy volunteers and patients receive OSU-2131 subcutaneously (SC) with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study.

GROUP II (PLACEBO): Healthy volunteers receive Dulbecco's phosphate-buffered saline (phosphate buffered saline [PBS]) SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study.

After completion of study intervention, healthy volunteers and patients are followed up at days 29 and 35 and then at 6, 16, 28, 40 and 56 weeks.

Conditions: Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 5, EBV-Related Lymphoproliferative Disorder, EBV-Related Malignant Neoplasm, Post-Transplant Lymphoproliferative Disorder
Being tested: Biospecimen Collection, Dulbecco''s Phosphate-Buffered Saline, Peptide Vaccine, QS21
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Dulbecco''s Phosphate-Buffered SalineDrug
Also called DPBS, PBS, Phosphate-Buffered Saline
Given SC
Peptide VaccineBiological
Given OSU-2131 SC
QS21Biological
Also called NIAID VEU 016, Purified Quillaja Saponin, QS-21, QS-21 Adjuvant
Given SC

Study groups in NCT06741072
Study group	Role	What they receive
Group I (OSU-2131, QS-21)	Experimental	Healthy volunteers and patients receive OSU-2131 SC with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Biological: Peptide Vaccine; Biological: QS21
Group II (placebo)	Placebo comparator	Healthy volunteers receive PBS SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Drug: Dulbecco''s Phosphate-Buffered Saline

What is being measured

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

Incidence of treatment-emergent adverse events
Will be coded to body systems and preferred terms using the Medical Dictionary for Regulatory Activities. Descriptive statistics, per treatment arm, will contain the number and percentage of subjects who experience at least one adverse event (AE), AE related to study treatment, serious AE, serious AE related to study treatment, grade 3 or 4 AE, and grade 3 or 4 related to study treatment. The number and percentage of subjects who discontinue treatment due to an AE will be provided, together with the number and percentage of subjects who die due to an AE.
Measured: From the first administration of treatment until the week 28 visit
Changes in laboratory parameters and vital signs
Changes will be summarized for subjects in each treatment arm. Baseline laboratory values will be summarized. The number and percentage of subjects with values below, within, and above normal range for each lab parameter will be summarized. Clinically significant abnormalities noted by the clinician during laboratory evaluations will be summarized by treatment arm.
Measured: At baseline and up to week 56
Pre- and post-injection vital signs
The number and percent of subjects who experience a clinically significant change in vitals from pre-injection to post-injection will be tabulated and summarized by treatment arm.
Measured: Up to week 4
Injection site reactions
The number and percent of subjects who experience induration at 10 minutes post injection and/or 60 minutes post injection will be tabulated and summarized by treatment arm. The number and percent of subjects who experience erythema at 10 minutes post injection and/or 60 minutes post injection will be tabulated and summarized by treatment arm.
Measured: At 10 and/or 60 minutes post injection on weeks 0, 2 and 4

Secondary outcomes (2)

Immune response
Will be defined as the change in pentamer RAK (RAKFKQLL) positive cells. The geometric mean of pentamer RAK positive cells will be reported at each time point with 95% confidence intervals, and the level of pentamer RAK positive cells will be plotted over time for each patient to visually identify changes in values from baseline through follow-up visits. BZLF1 HLA-B*08:01 RAK pentamers and cytometry by time-of-flight will be used to test for an immune response.
Measured: At baseline, day 0, and weeks 2, 4, 6, 12, 28, 40, and 56
Optimal immunologic dose (OID)
Percent CD3+, CD8+, RAK+ will be quantified for each patient. This will be completed for each dose level and following dose level 3 data analysis, a collective review of the flow cytometry will be performed to aid in determining the OID.
Measured: Up to week 12

Timeline

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

28 Jun 202631 Dec 2027

First posted18 Dec 2024
Study start28 Jun 2026
Primary completion31 Jul 2027 (estimated)
Study completion31 Dec 2027 (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 Chronic Kidney Disease, Stage 4Studies 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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 55 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06741072
Sponsor's protocol ID: OSU-20219
Other IDs: NCI-2024-09778
Status last verified: Jun 2026
First submitted: 16 Dec 2024
Last updated: 2 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Green M, Michaels MG, Gross T, Allen U, Bollard CM, Martinez O, Yamada M, Swerdlow SH. The IPTA Nashville Consensus Conference on Post-Transplant Lymphoproliferative Disorders After Solid Organ Transplantation in Children: Updates on Classification and Prevention-2026. Pediatr Transplant. 2026 Sep;30(9):e70445. doi: 10.1111/petr.70445.
PubMed 42720126

Interested in taking part?

The Ohio State University Comprehensive Cancer Center

800-293-5066

OSUCCCClinicaltrials@osumc.edu

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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1B Double Blinded Randomized Trial Evaluating Safety, Tolerability, and Immune Response of OSU-2131 a BZLF1 Peptide Vaccine With Stimulon™ QS-21 Solution Adjuvant in Healthy Volunteers and Patients Awaiting Solid Organ Transplantation
ClinicalTrials.gov ID: NCT06741072
Acronym / sponsor ID: OSU-20219
Conditions: Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 5, EBV-Related Lymphoproliferative Disorder, EBV-Related Malignant Neoplasm, Post-Transplant Lymphoproliferative Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 55 participants (estimated)
Lead sponsor: Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
Study start: 28 Jun 2026 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 18 Dec 2024 (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

PRIMARY OBJECTIVE:

Determine the overall safety profile of three different dose levels of OSU-2131 vaccination each with 50 mcg Stimulon (Trademark) Quillaja saponin (QS)-21 Solution adjuvant (QS-21), wherein the OSU-2131 doses are 80, 240 and 480 mcg in healthy volunteers and similar safety profile of the identified maximum tolerated dose (MTD) in patients awaiting solid organ transplantation.

SECONDARY OBJECTIVES:

Determine the optimal immunologic dose (OID) to OSU-2131 vaccination (with QS-21) in all dose cohorts of 80, 240, and 480 mcg OSU-2131 (healthy volunteers) and, upon completing safety assessment, patients awaiting solid organ transplant (PASOT).

After completion of study intervention, healthy volunteers and patients are followed up at days 29 and 35 and then at 6, 16, 28, 40 and 56 weeks.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group I (OSU-2131, QS-21)	Experimental	Procedure: Biospecimen Collection, Biological: Peptide Vaccine, Biological: QS21Healthy volunteers and patients receive OSU-2131 SC with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study.
Group II (placebo)	Placebo comparator	Procedure: Biospecimen Collection, Drug: Dulbecco''s Phosphate-Buffered SalineHealthy volunteers receive PBS SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B*08:01
Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive
Subjects must be seronegative for HIV
Subjects must be seronegative for hepatitis B and C
Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits

Key exclusion criteria (6 listed)

Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion
History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)
History of immune suppression or autoimmune disorder
Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable
Pregnant or breastfeeding subjects

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
Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection	Procedure or surgery	Group I (OSU-2131, QS-21), Group II (placebo)
Dulbecco''s Phosphate-Buffered SalineAlso: DPBS, PBS, Phosphate-Buffered SalineGiven SC	Drug	Group II (placebo)
Peptide VaccineGiven OSU-2131 SC	Biological	Group I (OSU-2131, QS-21)
QS21Also: NIAID VEU 016, Purified Quillaja Saponin, QS-21, QS-21 AdjuvantGiven SC	Biological	Group I (OSU-2131, QS-21)

Primary outcome

Incidence of treatment-emergent adverse events
Time frame: From the first administration of treatment until the week 28 visit
Will be coded to body systems and preferred terms using the Medical Dictionary for Regulatory Activities. Descriptive statistics, per treatment arm, will contain the number and percentage of subjects who experience at least one adverse event (AE), AE related to study treatment, serious AE, serious AE related to study treatment, grade 3 or 4 AE, and grade 3 or 4 related to study treatment. The number and percentage of subjects who discontinue treatment due to an AE will be provided, together with the number and percentage of subjects who die due to an AE.
Changes in laboratory parameters and vital signs
Time frame: At baseline and up to week 56
Changes will be summarized for subjects in each treatment arm. Baseline laboratory values will be summarized. The number and percentage of subjects with values below, within, and above normal range for each lab parameter will be summarized. Clinically significant abnormalities noted by the clinician during laboratory evaluations will be summarized by treatment arm.
Pre- and post-injection vital signs
Time frame: Up to week 4
The number and percent of subjects who experience a clinically significant change in vitals from pre-injection to post-injection will be tabulated and summarized by treatment arm.
Injection site reactions
Time frame: At 10 and/or 60 minutes post injection on weeks 0, 2 and 4
The number and percent of subjects who experience induration at 10 minutes post injection and/or 60 minutes post injection will be tabulated and summarized by treatment arm. The number and percent of subjects who experience erythema at 10 minutes post injection and/or 60 minutes post injection will be tabulated and summarized by treatment arm.

2 secondary outcomes

Immune response
Time frame: At baseline, day 0, and weeks 2, 4, 6, 12, 28, 40, and 56
Optimal immunologic dose (OID)
Time frame: Up to week 12

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 2 Jul 2026.
Derived from this study: PubMed 42720126Green M, Michaels MG, Gross T, Allen U, Bollard CM, Martinez O, Yamada M, Swerdlow SH. The IPTA Nashville Consensus Conference on Post-Transplant Lymphoproliferative Disorders After Solid Organ Transplantation in Children: Updates on Classification and Prevention-2026. Pediatr Transplant. 2026 Sep;30(9):e70445. doi: 10.1111/petr.70445.
The JameslineLink provided by the sponsor.

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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.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Timothy J Voorhees, MD principal investigator

Ohio State University Comprehensive Cancer Center

1 site 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 15 inclusion and 6 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 2 Jul 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. Some participants in this study may receive a placebo. 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?

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 The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: From the first administration of treatment until the week 28 visit). 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 NCT06741072, 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 2 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.