BK Virus InfectionPhase 3NCT04390113

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

A Phase 3 study testing Posoleucel (ALVR105) in people with BK Virus Infection and Hemorrhagic Cystitis, run by AlloVir at 56 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC). Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: BK Virus Infection, Hemorrhagic Cystitis
What is being tested?: Posoleucel (ALVR105)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 97 participants
Where: 56 sitesin 7 countries
Study dates: 18 Mar 2021to 30 Jan 2024
Phase: Phase 3
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 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria in order to be eligible to participate in the study:
Male or female ≥1 year of age.
Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
Diagnosed with HC based on the following criteria (all 3 criteria must be met):
Clinical signs and/or symptoms of cystitis.

Show all 9Show fewer

Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.

Who cannot join

Participants who meet any of the following criteria will be excluded from participation in the study:
Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
Evidence of active Grade >2 acute graft versus host disease (GVHD).
Uncontrolled or progressive bacterial or fungal infections.
Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).

Show all 10Show fewer

Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
Pregnant or lactating or planning to become pregnant.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

56 sites in 7 countries.

Country

City, postcode or hospital

56 sites in 7 countries

United States25 sites

Northside Hospital
Atlanta, Georgia, 30342
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio State University Medical Center (OSUMC)
Columbus, Ohio, 43210
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
City of Hope National Medical Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, 64108
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of Miami
Miami, Florida, 33136
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, 06520
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23284
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Moffitt
Tampa, Florida, 33612
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Italy7 sites

Azienda Ospedaliero-Universitaria Careggi
Florence
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan
IRCCS Ospedale San Raffaele
Milan
Ospedale Pediatrico Bambino Gesù
Roma
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome
Istituto Clinico Humanitas
Rozzano
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona

Other trials in Italy

South Korea7 sites

Chonnam National University Hwasun Hospital
Jeongnam
Asan Medical Center
Seoul
Pusan National University Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
Severance Hospital, Yonsei University Health System
Seoul

Other trials in South Korea

United Kingdom7 sites

University Hospitals Bristol NHS Foundation Trust
Bristol
Queen Elizabeth University Hospital - Glasgow
Glasgow
Great Ormond Street Hospital for Children
London
Hammersmith Hospital
London
The Royal Marsden NHS Foundation Trust
London
University College London Hospital
London
Nottingham University Hospitals
Nottingham

Other trials in United Kingdom

France5 sites

CHU de Lille - Hopital Claude Huriez
Lille
CHU de Nantes - Hôtel-Dieu
Nantes
AP-HP Hopital Saint-Louis
Paris
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite
IUCT-Oncopole
Toulouse

Other trials in France

Spain4 sites

Hospital Clinic Barcelona
Barcelona
Hospital Universitario La Paz
Madrid
Hospital Regional Universitario de Malaga
Málaga
Hospital Universitari i Politecnic La Fe
Valencia

Other trials in Spain

Sweden1 site

Karolinska University Hospital
Stockholm

Other trials in Sweden

About this study

Official title: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).

Read the detailed description

The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population).

Conditions: BK Virus Infection, Hemorrhagic Cystitis
Being tested: Posoleucel (ALVR105), Placebo
Keywords: Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel
Medical subject headings: Cystitis, Hemorrhagic

What participants receive

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

Posoleucel (ALVR105)Biological
Administered as 2-4 milliliter infusion, visually identical to placebo
PlaceboBiological
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Study groups in NCT04390113
Study group	Role	What they receive
Placebo	Placebo comparator	Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105) Receives: Biological: Placebo
Posoleucel (ALVR105)	Experimental	Administered as 2-4 milliliter infusion, visually identical to placebo Receives: Biological: Posoleucel (ALVR105)

What is being measured

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

Time to Resolution of Macroscopic Hematuria
Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.
Measured: Up to 24 weeks

Secondary outcomes (6)

Time Until Bladder Pain is Resolved
Measured: Until event occurrence through Week 24
Days in the Hospital for Any Reason
Measured: Until event occurrence through Week 24
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)
Grading of acute GVHD is reported according to CTCAE version 5.0 which ranges from Grade 0 (best/no disease) to Grade IV (worst). Participants with Grade I-IV are included.
Measured: Up to 24 weeks
Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)
CRS is defined as a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak (hypoxia), and end organ dysfunction.
Measured: Up to 24 weeks
Time to Resolution for All Target Viruses
Measured: Until event occurrence through Week 24
Average Daily Bladder Pain
Measured: Until event occurrence through Week 6

Timeline

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

18 Mar 202130 Jan 2024

First posted15 May 2020
Study start18 Mar 2021
Primary completion30 Jan 2024
Study completion30 Jan 2024

Why it stopped: Study discontinued as DSMB determined it was futile. No safety concerns were noted.

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for BK Virus InfectionStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04390113
Sponsor's protocol ID: AVM-003-HC
Status last verified: Apr 2024
First submitted: 12 May 2020
Last updated: 14 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
PubMed 28783452
Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
PubMed 38597860

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

RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Kidney Diseases, Kidney Injury
Active, not recruitingPhase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection

All BK Virus Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)
ClinicalTrials.gov ID: NCT04390113
Acronym / sponsor ID: AVM-003-HC
Conditions: BK Virus Infection, Hemorrhagic Cystitis
Keywords: Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study discontinued as DSMB determined it was futile. No safety concerns were noted.
Enrolment: 97 participants (actual)
Lead sponsor: AlloVirIndustry (pharma, biotech, devices)
Study start: 18 Mar 2021 (actual)
Primary completion: 30 Jan 2024 (actual)
Study completion: 30 Jan 2024 (actual)
First posted: 15 May 2020 (actual)
Results: Posted 14 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Biological: PlaceboAdministered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Posoleucel (ALVR105)	Experimental	Biological: Posoleucel (ALVR105)Administered as 2-4 milliliter infusion, visually identical to placebo

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Participants must meet all of the following criteria in order to be eligible to participate in the study:
Male or female ≥1 year of age.
Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
Diagnosed with HC based on the following criteria (all 3 criteria must be met):

Key exclusion criteria (10 listed)

Participants who meet any of the following criteria will be excluded from participation in the study:
Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose >0.5 mg/kg/day or equivalent).
Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
Evidence of active Grade >2 acute graft versus host disease (GVHD).
Uncontrolled or progressive bacterial or fungal infections.

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
Posoleucel (ALVR105)Administered as 2-4 milliliter infusion, visually identical to placebo	Biological	Posoleucel (ALVR105)
PlaceboAdministered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)	Biological	Placebo

Primary outcome

Time to Resolution of Macroscopic Hematuria
Time frame: Up to 24 weeks
Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.

6 secondary outcomes

Time Until Bladder Pain is Resolved
Time frame: Until event occurrence through Week 24
Days in the Hospital for Any Reason
Time frame: Until event occurrence through Week 24
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)
Time frame: Up to 24 weeks
Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)
Time frame: Up to 24 weeks
Time to Resolution for All Target Viruses
Time frame: Until event occurrence through Week 24
Average Daily Bladder Pain
Time frame: Until event occurrence through Week 6

Results and safety

Results posted to the registry on 14 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Posoleucel (ALVR105)	57	37
Placebo	40	26

Primary outcome: Time to Resolution of Macroscopic Hematuria

Time frame: Up to 24 weeks. Median (95% Confidence Interval). Unit: Days

Measure	Posoleucel (ALVR105) n = 48	Placebo n = 38
Value	36 (22.0 to 63.0)	31 (18.0 to 63.0)

Posoleucel (ALVR105) vs Placebo: Hazard Ratio (HR): 0.92 (95% CI 0.55 to 1.55), p = 0.6253, Log Rank

Population analysed: BK Intent-to-Treat \[ITT\] Population: All patients randomized who had BKV in their urine at baseline.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Posoleucel (ALVR105)	28 of 57 (49.1%)	54 of 57 (94.7%)	2 of 57
Placebo	19 of 39 (48.7%)	36 of 39 (92.3%)	1 of 40

Limitations and caveats (from the sponsor): AlloVir decided to discontinue the trial on 22-Dec-2023 following a pre-planned DSMB futility analysis concluding the study was unlikely to meet its primary endpoint; no safety concerns were identified.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28783452Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
Derived from this study: PubMed 38597860Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
Individual participant dataSharing planned: No

Related trials for BK Virus Infection

RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
Kidney Diseases, Kidney Injury
Active, not recruitingPhase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection

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.

The record lists no contact. Use the official record to reach the sponsor.

56 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Posoleucel (ALVR105) in people with BK Virus Infection and Hemorrhagic Cystitis, run by AlloVir at 56 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Italy, South Korea, United Kingdom, France and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 14 May 2024). 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?

Time to Resolution of Macroscopic Hematuria (time frame: Up to 24 weeks). 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 NCT04390113, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.