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Lymphoma, Non-HodgkinPhase 1/2WaveSpan-008NCT07519772

A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)

A Phase 1/2 study testing MK-1045 in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by Merck Sharp & Dohme LLC at 52 sites in 16 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MK-1045
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
52 sitesin 16 countries
Study dates
3 May 2026to 1 Apr 2031
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

  • The main inclusion criteria include but are not limited to the following:
  • Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
  • Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
  • DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
  • Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
  • Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
Show all 10Show fewer
  • Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
  • Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
  • Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
  • Has radiographically measurable disease per Lugano Response Criteria.

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has received a solid organ transplant.
  • Had or has clinically relevant central nervous system (CNS) diseases.
  • Has a history of serious cardiovascular or cerebrovascular diseases.
  • Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Show all 15Show fewer
  • Has received a live or live-attenuated vaccine within 30 days of randomization.
  • Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
  • Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
  • Has known active CNS lymphoma or involvement.
  • Has active autoimmune disease that required systemic treatment in the past 2 years.
  • Has active infection requiring systemic therapy.
  • Has a history of severe bleeding disorders.
  • Has not recovered from major surgery or has ongoing surgical complications.
  • Has diagnosis of primary mediastinal B-cell lymphoma.

Trial locations and contacts

52 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

52 sites in 16 countries

China5 sites, 5 recruiting

  • Beijing Cancer hospital ( Site 1701)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, +86 010-88196922

    Recruiting

  • Fujian Provincial Cancer Hospital.. ( Site 1704)

    Fuzhou, Fujian, 350014

    Study Coordinator, +86059183660063

    Recruiting

  • Sun Yat-Sen University Cancer Center ( Site 1712)

    Guangzhou, Guangdong, 510060

    Study Coordinator, +8602087343349

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 1711)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, 8602138196379

    Recruiting

  • Henan Cancer Hospital ( Site 1702)

    Zhengzhou, Henan, 450003

    Study Coordinator, 65587791

    Recruiting

Other trials in China

Israel5 sites, 5 recruiting

  • Carmel Hospital ( Site 0602)

    Haifa, 3436212

    Study Coordinator, +97248250211

    Recruiting

  • Shaare Zedek Medical Center ( Site 0603)

    Jerusalem, 9103102

    Study Coordinator, +972544922952

    Recruiting

  • Haddasah Medical Center ( Site 0600)

    Jerusalem, 9112001

    Study Coordinator, +972539101736

    Recruiting

  • Sheba Medical Center ( Site 0601)

    Ramat Gan, 5265601

    Study Coordinator, 97235303030

    Recruiting

  • Sourasky Medical Center. ( Site 0604)

    Tel Aviv, 6423906

    Study Coordinator, +97236974444

    Recruiting

Other trials in Israel

Spain5 sites, 5 recruiting

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)

    Badalona, Barcelona, 08916

    Study Coordinator, 34934978387

    Recruiting

  • Hospital Universitari Vall de Hebron ( Site 1102)

    Barcelona, 08035

    Study Coordinator, +34 932746000

    Recruiting

  • Hospital Universitario Gregorio Maranon ( Site 1101)

    Madrid, 28007

    Study Coordinator, +34915868888

    Recruiting

  • Hospital Universitario 12 de Octubre ( Site 1105)

    Madrid, 28041

    Study Coordinator, +34917792809

    Recruiting

  • Hospital Virgen de la Victoria ( Site 1104)

    Málaga, Malaga, 29010

    Study Coordinator, 34951032508

    Recruiting

Other trials in Spain

Turkey (Türkiye)5 sites, 5 recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)

    Ankara, 06230

    Study Coordinator, +903123052941

    Recruiting

  • Antalya Egitim ve Arastirma Hastanesi ( Site 1003)

    Antalya, 7100

    Study Coordinator, +905315269050

    Recruiting

  • Koç Üniversitesi Hastanesi ( Site 1001)

    Istanbul, 34010

    Study Coordinator, 02124678700

    Recruiting

  • Medipol Mega Universite Hastanesi ( Site 1002)

    Istanbul, 34214

    Study Coordinator, +905426202524

    Recruiting

  • Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 1005)

    Samsun, 55270

    Study Coordinator, +905442398796

    Recruiting

Other trials in Turkey (Türkiye)

United States4 sites, 4 recruiting

  • University Hospitals of Cleveland ( Site 0113)

    Cleveland, Ohio, 44106

    Study Coordinator, 216-844-0139

    Recruiting

  • Colorado Blood Cancer Institute ( Site 7000)

    Denver, Colorado, 80218

    Study Coordinator, 720-748-4800

    Recruiting

  • Cedar Sinai Cancer Center ( Site 0119)

    Los Angeles, California, 90048

    Study Coordinator, 310-423-3277

    Recruiting

  • SCRI Oncology Partners ( Site 0100)

    Nashville, Tennessee, 37203

    Study Coordinator, 844-482-4812

    Recruiting

Other trials in United States

Argentina4 sites, 4 recruiting

  • Hospital Aleman ( Site 1400)

    CABA, C1118AAT

    Study Coordinator, +541148277000

    Recruiting

  • Instituto Alexander Fleming ( Site 1404)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Hospital Universitario Austral ( Site 1402)

    Pilar, Buenos Aires, B1629AHJ

    Study Coordinator, +54 (0230) 438-8888

    Recruiting

  • Sanatorio Nuestra Senora del Rosario ( Site 1403)

    Rosario, Santa Fe Province, 2001

    Study Coordinator, +5493416149225

    Recruiting

Other trials in Argentina

Italy4 sites, 4 recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Ematologia Oncologica ( Site 0700)

    Campania, Napoli, 80131

    Study Coordinator, 00390815903382

    Recruiting

  • INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)

    Candiolo, Piedmont, 10060

    Study Coordinator, +390119933355

    Recruiting

  • Istituto Europeo di Oncologia IRCCS ( Site 0702)

    Milan, 20141

    Study Coordinator, 0039 02 57489403

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705)

    Roma, 00168

    Study Coordinator, 00390630154180

    Recruiting

Other trials in Italy

Poland4 sites, 4 recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)

    Gliwice, Silesian Voivodeship, 44-102

    Study Coordinator, +48322788237

    Recruiting

  • Pratia Onkologia Katowice ( Site 0902)

    Katowice, Silesian Voivodeship, 40-519

    Study Coordinator, +48501714019

    Recruiting

  • Pratia MCM Krakow ( Site 0903)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48122958160

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462000

    Recruiting

Other trials in Poland

Australia3 sites, 3 recruiting

  • Royal Adelaide Hospital ( Site 0205)

    Adelaide, South Australia, 5000

    Study Coordinator, +61 466 650 767

    Recruiting

  • Box Hill Hospital ( Site 0202)

    Box Hill, Victoria, 3128

    Study Coordinator, +611300342255

    Recruiting

  • Townsville University Hospital ( Site 0204)

    Townsville, Queensland, 4814

    Study Coordinator, 0744331111

    Recruiting

Other trials in Australia

Brazil3 sites, 3 recruiting

  • Hospital Erasto Gaertner ( Site 1503)

    Curitiba, Paraná, 81520-060

    Study Coordinator, 554133615104

    Recruiting

  • Hospital das Clinicas FMUSP ( Site 1502)

    São Paulo, São Paulo, 01246-000

    Study Coordinator, 551138933504

    Recruiting

  • Hospital Paulistano ( Site 1504)

    São Paulo, 01321-001

    Study Coordinator, 55113141-1083

    Recruiting

Other trials in Brazil

Canada2 sites, 2 recruiting

  • Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0305)

    Montreal, Quebec, H1T 2M4

    Study Coordinator, 514-252-3400

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0301)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416-946-4558

    Recruiting

Other trials in Canada

Chile2 sites, 2 recruiting

  • Clínica Alemana de Santiago ( Site 1608)

    Santiago, Region M. de Santiago, 7650568

    Study Coordinator, 56222101111 ext 6218

    Recruiting

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 1603)

    Santiago, Region M. de Santiago, 8330034

    Study Coordinator, +56934331806

    Recruiting

Other trials in Chile

South Korea2 sites, 2 recruiting

  • Seoul National University Hospital ( Site 0800)

    Seoul, 03080

    Study Coordinator, +82220722228

    Recruiting

  • The Catholic University of Korea, Yeouido St. Mary's Hospital ( Site 0801)

    Seoul, 07345

    Study Coordinator, +82237791049

    Recruiting

Other trials in South Korea

United Kingdom2 sites, 2 recruiting

  • The Christie NHS Foundation Trust ( Site 1300)

    Manchester, M20 4BX

    Study Coordinator, +4401614468201

    Recruiting

  • Derriford Hospital ( Site 1304)

    Plymouth, Devon, Pl6 8DH

    Study Coordinator, +441752431043

    Recruiting

Other trials in United Kingdom

France1 site, 1 recruiting

  • Hopital Saint Louis ( Site 0405)

    Paris, Île-de-France Region, 75010

    Study Coordinator, +330142495384

    Recruiting

Other trials in France

Germany1 site, 1 recruiting

  • UKGM Gießen/Marburg ( Site 0505)

    Giessen, Hesse, 35392

    Study Coordinator, +49 64198542651

    Recruiting

Other trials in Germany

About this study

Official title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma

Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system.

In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer.

The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.

Being tested
MK-1045
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • MK-1045Biological

    Also called CN-201

    Intravenous (IV) Infusion or Subcutaneous (SC) injection

Study groups in NCT07519772
Study groupRoleWhat they receive
Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose OptimizationExperimentalParticipants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
Receives: Biological: MK-1045
Arm 2: FL MK-1045 Longer Dosing IntervalExperimentalParticipants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
Receives: Biological: MK-1045
Arm 3: FL MK-1045 Subcutaneous AdministrationExperimentalParticipants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation.
Receives: Biological: MK-1045
Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose OptimizationExperimentalParticipants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
Receives: Biological: MK-1045

What is being measured

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

  1. Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 49 months

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 12 months

  3. Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT)

    DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days) that results in a change to a given dose or a delay in initiating the next treatment.

    Measured: Up to approximately 28 days

  4. Arms 1, 2, and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR)

    ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). In Arms 1, 2, and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 49 months

Secondary outcomes (8)

  1. Arms 1, 2, and 4: Duration of Response (DOR) per Lugano Response Criteria as assessed by BICR

    For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response will be evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by BICR will be presented for Arms 1, 2, and 4.

    Measured: Up to approximately 49 months

  2. Arm 3: DOR per Lugano Response Criteria as assessed by Investigator

    For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response will be evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by the Investigator will be presented for Arm 3.

    Measured: Up to approximately 49 months

  3. Area Under the Concentration-time Curve Measured at Steady State (AUCss) of MK-1045

    Blood samples will be collected to determine the AUCss of MK-1045 in plasma.

    Measured: Pre-dose and at designated time points post-dose up to 12 months

  4. Trough Concentration (Ctrough) of MK-1045

    Blood samples will be collected to determine the Ctrough of MK-1045 in plasma.

    Measured: Pre-dose and at designated time points post-dose up to 12 months

  5. Maximum Serum Concentration (Cmax) of MK-1045

    Blood samples will be collected to determine the Cmax of MK-1045 in plasma.

    Measured: Pre-dose and at designated time points post-dose up to 12 months

  6. Arms 1, 2, and 4: Time to Maximum Serum Concentration (Tmax) of MK-1045

    Blood samples will be collected to determine the Tmax of MK-1045 in plasma.

    Measured: Pre-dose and at designated time points post-dose up to 12 months

  7. Arm 3: Absolute Bioavailability Expressed as a Percentage (F%) of MK-1045

    Blood samples will be collected to determine the F% of MK-1045 in plasma.

    Measured: Pre-dose and at designated time points post-dose up to 12 months

  8. Arm 3: ORR per Lugano Response Criteria as assessed by Investigator

    ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). In Arm 3, the percentage of participants who experience CR or PR as assessed by the Investigator will be presented.

    Measured: Up to approximately 49 months

Timeline

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

  1. First posted9 Apr 2026
  2. Study start3 May 2026
  3. Primary completion1 Jul 2030 (estimated)
  4. Study completion1 Apr 2031 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07519772
Sponsor's protocol ID
1045-008
Other IDs
U1111-1324-8720, 2025-523005-15-00, MK-1045-008, 2025
Acronym
WaveSpan-008
Status last verified
Oct 2026
First submitted
3 Apr 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MK-1045 in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by Merck Sharp & Dohme LLC at 52 sites in 16 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 10 inclusion and 15 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China, Israel, Spain, Turkey (Türkiye), United States and 11 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 49 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 NCT07519772.

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 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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