Extranodal NK/T-cell Lymphoma, Nasal TypePhase 2NCT04414163

A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

A Phase 2 study testing IMC-001 in people with Extranodal NK/T-cell Lymphoma, Nasal Type and Extranodal NK/T-cell Lymphoma, run by ImmuneOncia Therapeutics Inc. at 5 sites in South Korea.

Active, not recruiting

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

Official record

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Trial summary

This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK/T-cell Lymphoma
What is being tested?: IMC-001
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 5 sitesSouth Korea
Study dates: 27 Oct 2020to 28 Feb 2027
Phase: Phase 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

ENKTL diagnosis;
Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type
At least 1 previous line of systemic therapy
Documented disease progression of last therapy
Adult age(as defined by respective country)
The nature of the study and voluntarily sign an ICF
ECOG 0 or1
Adequate hematologic function, hepatic function, and renal function

Who cannot join

Previously treated with an anti-PD-L1 or anti-PD-1 antibody
Known presence of symptomatic CNS metastases
Prior allogeneic HSCT or solid organ transplantation
Any active autoimmune disease or a documented history of autoimmune disease
Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
Pregnant or lactating

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

South Korea5 sites

Chonnam National University Hwasun Hospital
Gwangju
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Ulsan University Hospital
Ulsan

Other trials in South Korea

About this study

Official title: An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type

This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type

Read the detailed description

IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK/T-cell Lymphoma
Being tested: IMC-001
Keywords: IMC-001, IMC-001-201, DISTINKT
Medical subject headings: Lymphoma, Extranodal NK-T-Cell

What participants receive

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

IMC-001Drug
Also called Danburstotug
Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)

Study groups in NCT04414163
Study group	Role	What they receive
IMC-001	Experimental	Single Dose level (IMC-001 20mg/kg, every 2 weeks) Receives: Drug: IMC-001

What is being measured

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

Occurrence of Objective Response Rate(ORR)
Lugano criteria with LYRIC modification
Measured: through study completion, an average of 1 year

Secondary outcomes (12)

Evaluate safety of IMC-001
Terms, frequency, severity and seriousness of AEs and relationship of AEs to IMC-001
Measured: through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate
Complete Response (CR) rate, (Unit of Measure: Percentage of participants)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
3. based on response as determined by the investigator per the Lugano criteria
Measured: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
Disease Control Rate (DCR), (Unit of Measure: Percentage of participants)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteria
Measured: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
Progression-Free Survival (PFS), (Unit of Measure: Months)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
3. based on response as determined by the investigator per the Lugano criteria
Measured: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
Duration of Response (DOR), (Unit of Measure: Months)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteria
Measured: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
Time to Progression (TTP), (Unit of Measure: Months)
1. Variables determined by the centralized independent assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteria
Measured: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR)
Overall Response Rate (ORR), (Unit of Measure: Percentage of participants)
1. Variables determined by the investigator assessment per the Lugano criteria with LYRIC modification
2. based on response as determined by the investigator per the Lugano criteria
Measured: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS)
Overall Survival (OS), (Unit of Measure: Months)
Measured: through study completion, an average of 1 year
Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough
The trough level or trough concentration (Ctrough) of IMC-001 measured at specified time points.
Measured: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)
Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax
The maximum observed serum concentration (Cmax) of IMC-001 observed during dosing interval.
Measured: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)
Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)
Incidence of anti-drug antibody (ADA) (including serum titers of anti-IMC-001 antibodies) The percentage of patients demonstrating anti-IMC-001 antibodies will be calculated.
Measured: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)
Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity
Correlation Between ADA and Drug Exposure and Activity The Spearman nonparametric correlation coefficient will be calculated to quantify the relationship between titer of anti-IMC-001 antibodies and exposure and activity.
Measured: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

Timeline

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

27 Oct 202028 Feb 2027

First posted4 Jun 2020
Study start27 Oct 2020
Primary completion23 Jul 2024
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Extranodal NK/T-cell Lymphoma, Nasal TypeStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04414163
Sponsor's protocol ID: IMC-001-201
Status last verified: Sep 2026
First submitted: 26 May 2020
Last updated: 24 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

W.S.Kim, et al. AI-Based Membrane Specific PD-L1 and Tumor Immune Microenvironment as Predictive Biomarkers for Danburstotug in Relapsed or Refractory Extranodal NK/T cell Lymphoma (R/R ENKTL): Insights from A Phase II Trial (DISTINKT). ICKSH; 2026; Seoul, Korea; AK-0083.
W.S.Kim, et al. AI-based membrane specific PD-L1 and tumor immune microenvironment (TIME) subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). T-cell lymphoma forum; 2026; San Diego, California, USA; TCLF38.
W.S.Kim, et al. Artificial intelligence (AI)-based membrane specific PD-L1 and immune subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). ASH; 2025; Orlando, USA; 5426.
T.W.Sung, et al. Optimizing IMC-001 Dosage Regimens Using Target Mediated Drug Disposition Model: Enhancing Therapeutic Efficacy and Safety in Cancer Treatment. PAGE; 2024; Rome, Italy; Abstract 10927.
W.S.Kim, et al. ENHANCED EFFICACY AND SAFETY FROM PHASE 2 STUDY OF IMC-001, ANTI-PD-L1 ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY EXTRANODAL NK/T CELL LYMPHOMA (R/R ENKTL), NASAL TYPE: DISTINKT STUDY. EHA; 2024; Madrid, Spain; P1213.
J.H.Jeon, et al. Exposure-response (E-R) relationship between PD-L1 recombinant monoclonal antibody IMC-001 in relapsed or refractory extranodal NK/T cell lymphoma nasal type patients. ACoP; 2024; Phoenix, Arizona, USA; T-058.
W.S.Kim, et al. Phase 2 study to investigate the efficacy and safety of IMC-001, anti-PD-L1 antibody, in Patients with relapsed or refractory extranodal NK/T Cell lymphoma, nasal Type: DISTINKT Study. ICML; 2023; Lugano, Switzerland; Abstract 433.
W.S.Kim, et al. Efficacy and Safety of IMC-001, anti-PD-L1 antibody, in Patients with Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (R/R ENKTL). ESMO; 2022; Singapore, Republic of Singapore; Abstract 494.

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

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All Extranodal NK/T-cell Lymphoma, Nasal Type trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
ClinicalTrials.gov ID: NCT04414163
Acronym / sponsor ID: IMC-001-201
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK/T-cell Lymphoma
Keywords: IMC-001, IMC-001-201, DISTINKT
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 23 participants (actual)
Lead sponsor: ImmuneOncia Therapeutics Inc.Industry (pharma, biotech, devices)
Study start: 27 Oct 2020 (actual)
Primary completion: 23 Jul 2024 (actual)
Study completion: 28 Feb 2027 (estimated)
First posted: 4 Jun 2020 (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.

This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IMC-001	Experimental	Drug: IMC-001Single Dose level (IMC-001 20mg/kg, every 2 weeks)

Who may qualify

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

Key inclusion criteria (8 listed)

ENKTL diagnosis;
Adult age(as defined by respective country)
The nature of the study and voluntarily sign an ICF
ECOG 0 or1
Adequate hematologic function, hepatic function, and renal function

Key exclusion criteria (6 listed)

Previously treated with an anti-PD-L1 or anti-PD-1 antibody
Known presence of symptomatic CNS metastases
Prior allogeneic HSCT or solid organ transplantation
Any active autoimmune disease or a documented history of autoimmune disease
Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus

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
IMC-001Also: DanburstotugSingle dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)	Drug	IMC-001

Primary outcome

Occurrence of Objective Response Rate(ORR)
Time frame: through study completion, an average of 1 year
Lugano criteria with LYRIC modification

12 secondary outcomes

Evaluate safety of IMC-001
Time frame: through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate
Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR)
Time frame: The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.
Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS)
Time frame: through study completion, an average of 1 year
Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough
Time frame: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)
Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax
Time frame: Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days)
Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)
Time frame: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)
Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity
Time frame: Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit)

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 24 Sep 2026.
BackgroundW.S.Kim, et al. AI-Based Membrane Specific PD-L1 and Tumor Immune Microenvironment as Predictive Biomarkers for Danburstotug in Relapsed or Refractory Extranodal NK/T cell Lymphoma (R/R ENKTL): Insights from A Phase II Trial (DISTINKT). ICKSH; 2026; Seoul, Korea; AK-0083.
BackgroundW.S.Kim, et al. AI-based membrane specific PD-L1 and tumor immune microenvironment (TIME) subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). T-cell lymphoma forum; 2026; San Diego, California, USA; TCLF38.
BackgroundW.S.Kim, et al. Artificial intelligence (AI)-based membrane specific PD-L1 and immune subtypes as predictive biomarkers for danburstotug in relapsed or refractory extranodal NK/T cell lymphoma (R/R ENKTL): Insights from the phase II trial (DISTINKT). ASH; 2025; Orlando, USA; 5426.
BackgroundT.W.Sung, et al. Optimizing IMC-001 Dosage Regimens Using Target Mediated Drug Disposition Model: Enhancing Therapeutic Efficacy and Safety in Cancer Treatment. PAGE; 2024; Rome, Italy; Abstract 10927.
BackgroundW.S.Kim, et al. ENHANCED EFFICACY AND SAFETY FROM PHASE 2 STUDY OF IMC-001, ANTI-PD-L1 ANTIBODY, IN PATIENTS WITH RELAPSED OR REFRACTORY EXTRANODAL NK/T CELL LYMPHOMA (R/R ENKTL), NASAL TYPE: DISTINKT STUDY. EHA; 2024; Madrid, Spain; P1213.
BackgroundJ.H.Jeon, et al. Exposure-response (E-R) relationship between PD-L1 recombinant monoclonal antibody IMC-001 in relapsed or refractory extranodal NK/T cell lymphoma nasal type patients. ACoP; 2024; Phoenix, Arizona, USA; T-058.
BackgroundW.S.Kim, et al. Phase 2 study to investigate the efficacy and safety of IMC-001, anti-PD-L1 antibody, in Patients with relapsed or refractory extranodal NK/T Cell lymphoma, nasal Type: DISTINKT Study. ICML; 2023; Lugano, Switzerland; Abstract 433.
BackgroundW.S.Kim, et al. Efficacy and Safety of IMC-001, anti-PD-L1 antibody, in Patients with Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (R/R ENKTL). ESMO; 2022; Singapore, Republic of Singapore; Abstract 494.
Individual participant dataSharing planned: No

Related trials for Extranodal NK/T-cell Lymphoma, Nasal Type

Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Won Seog Kim principal investigator

Samsung Medical Center, Republic of Korea

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMC-001 in people with Extranodal NK/T-cell Lymphoma, Nasal Type and Extranodal NK/T-cell Lymphoma, run by ImmuneOncia Therapeutics Inc. at 5 sites in South Korea.

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 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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 South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 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?

Occurrence of Objective Response Rate(ORR) (time frame: through study completion, an average of 1 year). 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 NCT04414163, which also lists 8 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 24 Sep 2026.