Gastric CancerPhase 1NCT06464965

Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer

A Phase 1 study testing CB CAR-NK18.2, Cyclophosphamide and Fludarabine in people with Gastric Cancer and Pancreas Adenocarcinoma, run by Zhejiang Provincial People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Main Objective: To study the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of cord blood-derived CAR-NK cells (CB CAR-NK182) targeting Claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer, Pancreas Adenocarcinoma
What is being tested?: CB CAR-NK18.2, Cyclophosphamide and Fludarabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: 3 Jul 2024to 30 Dec 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female aged 18-75 years (inclusive);
Understands and voluntarily signs a written informed consent form, and is willing and able to comply with all trial requirements;
Patients with advanced gastric cancer and advanced pancreatic cancer confirmed by histopathology or cytology, who have failed standard treatment or cannot tolerate standard treatment, including but not limited to: pancreatic cancer and gastric cancer;
Immunohistochemical (IHC) detection of CLDN18.2, the positive expression of CLDN18.2 in tumors must be ≥ 10%;
At least 1 measurable lesion according to RECIST 1.1;
ECOG score is 0-1;

Show all 9Show fewer

All toxic reactions caused by previous antineoplastic therapy were resolved to grade 0-1 (according to NCI CTCAE 5.0 edition); Expected survival ≥ 12 weeks;
In addition to the primary disease, no serious hematology, heart and lung, liver and kidney disease, laboratory tests meet the following requirements:
Peripheral blood neutrophil absolute value ≥ 2000/mm3, platelet ≥ 50000/mm3 Serum creatinine ≤ 1.5mg/dL;ALT (alanine aminotransferase)/AST (aspartate aminotransferase) below 2.5 times the upper limit of normal; Total bilirubin ≤ 1.5mg/dL; Cardiac ejection fraction (EF)≥ 50%; International standard ratio (INR) or prothrombin time (PT) below 1.5 times the upper limit of normal; Activated partial coagulation time (aPTT) below 1.5 times the upper limit of normal; 10. Women of childbearing potential must have a negative serum pregnancy test and agree to effective birth control during the treatment phase and within 12 months after injection of CAR-NK cells; Male patients must agree to use effective birth control during the study and for 12 months after injection of CAR-NK cells.

Who cannot join

History of other tumors;
Patients who have received CAR-T,CAR-NK,TCR-T and other cell therapy targeting Claudin18.2 within 3 months before study treatment;
Patients with hypersensitivity to cell therapy or any related drugs;
Active autoimmune diseases;
Active infections that cannot be controlled;
HIV infection, uncontrolled HBV, HCV and syphilis infections;

Show all 12Show fewer

Have metastatic disease of the central nervous system (CNS), leptomeningeal disease or spinal cord compression;
Patients with severe heart disease;
Patients with unstable/active ulcers or bleeding from the digestive system;
Patients with a history of bleeding or bleeding tendency in the digestive system;
Pregnant or lactating women;
There are other factors that the researcher believes are not suitable for participating in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Phase I Clinical Study of Cord Blood-Derived CAR-NK Cells Targeting Claudin18.2 in the Treatment of Advanced Gastric Cancer and Advanced Pancreatic Cancer

Secondary Objective: To evaluate the efficacy of CB CAR-NK182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), etc.

To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;

Conditions: Gastric Cancer, Pancreas Adenocarcinoma
Being tested: CB CAR-NK18.2, Cyclophosphamide, Fludarabine
Keywords: Gastric Cancer, Pancreatic Adenocarcinoma, CAR-NK, Claudin18.2
Medical subject headings: Stomach Neoplasms

What participants receive

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

CB CAR-NK18.2Biological
Administered via intravenous infusion on Days 0, 3, and 7.
Three dose levels are planned:
Dose Level 1: 2×10^6 cells/kg/infusion Dose Level 2: 8×10^6 cells/kg/infusion Dose Level 3: 16×10^6 cells/kg/infusion
CyclophosphamideDrug
Part of the lymphodepletion regimen. Administered at 500 mg/m^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.
FludarabineDrug
Part of the lymphodepletion regimen. Administered at 30 mg/m^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.

Study groups in NCT06464965
Study group	Role	What they receive
CB CAR-NK182 Dose Escalation	Experimental	Participants will receive a lymphodepleting conditioning regimen (FC regimen) followed by three intravenous infusions of Claudin18.2-targeted umbilical cord blood-derived CAR-NK cells (CB CAR-NK182) on days 0, 3, and 7. The study follows a "3+3" dose-escalation design with three planned dose levels. Three dose levels: Dose Level 1 (2×10⁶ cells/kg/infusion on days 0, 3, and 7), Dose Level 2 (8×10⁶ cells/kg/infusion on days 0, 3, and 7), Dose Level 3 (16×10⁶ cells/kg/infusion on days 0, 3, and 7). 3-6 subjects will be enrolled per dose level. Each subject will be observed for at least 28 days after the first infusion, with a long-term follow-up period of 2 years post-first infusion. Standard "3+3" rules apply for DLT observation and dose escalation decisions. Receives: Biological: CB CAR-NK18.2; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

MTD
Maximum Tolerated Dose
Measured: 1 month
DLT
Dose-Dependent Toxicity
Measured: 1 month

Secondary outcomes (5)

ORR
Overall objective tumor response rate
Measured: 3 years
DCR
Disease control rate
Measured: 3 years
PFS
progression-free survival
Measured: 3 years
OS
overall survival
Measured: 3 years
DOR
duration of response
Measured: 3 years

Timeline

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

3 Jul 202430 Dec 2025

First posted18 Jun 2024
Study start3 Jul 2024
Primary completion10 Oct 2025
Study completion30 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06464965
Sponsor's protocol ID: 2024-105
Status last verified: Jul 2026
First submitted: 13 Jun 2024
Last updated: 9 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902
Fanotto V, Cordio S, Pasquini G, Fontanella C, Rimassa L, Leone F, Rosati G, Santini D, Giampieri R, Di Donato S, Tomasello G, Silvestris N, Pietrantonio F, Battaglin F, Avallone A, Scartozzi M, Lutrino ES, Melisi D, Antonuzzo L, Pellegrino A, Torri V, Aprile G. Prognostic factors in 868 advanced gastric cancer patients treated with second-line chemotherapy in the real world. Gastric Cancer. 2017 Sep;20(5):825-833. doi: 10.1007/s10120-016-0681-6. Epub 2016 Dec 27.
PubMed 28028664
Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Cheng K, Song C, Wu H, Eng-Wong J, Kim K, Kang YK. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018 Oct;19(10):1372-1384. doi: 10.1016/S1470-2045(18)30481-9. Epub 2018 Sep 11.
PubMed 30217672
Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.
PubMed 28343975
Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PubMed 20728210
Heinemann V, Ebert MP, Laubender RP, Bevan P, Mala C, Boeck S. Phase II randomised proof-of-concept study of the urokinase inhibitor upamostat (WX-671) in combination with gemcitabine compared with gemcitabine alone in patients with non-resectable, locally advanced pancreatic cancer. Br J Cancer. 2013 Mar 5;108(4):766-70. doi: 10.1038/bjc.2013.62. Epub 2013 Feb 14.
PubMed 23412098
Cappell KM, Kochenderfer JN. Long-term outcomes following CAR T cell therapy: what we know so far. Nat Rev Clin Oncol. 2023 Jun;20(6):359-371. doi: 10.1038/s41571-023-00754-1. Epub 2023 Apr 13.
PubMed 37055515
Khawar MB, Gao G, Rafiq M, Shehzadi A, Afzal A, Abbasi MH, Sheikh N, Afzal N, Ashraf MA, Hamid SE, Shahzaman S, Kawish N, Sun H. Breaking down barriers: The potential of smarter CAR-engineered NK cells against solid tumors. J Cell Biochem. 2023 Aug;124(8):1082-1104. doi: 10.1002/jcb.30460. Epub 2023 Aug 11.
PubMed 37566723
Gowrikumar S, Singh AB, Dhawan P. Role of Claudin Proteins in Regulating Cancer Stem Cells and Chemoresistance-Potential Implication in Disease Prognosis and Therapy. Int J Mol Sci. 2019 Dec 20;21(1):53. doi: 10.3390/ijms21010053.
PubMed 31861759
Kyuno D, Takasawa A, Takasawa K, Ono Y, Aoyama T, Magara K, Nakamori Y, Takemasa I, Osanai M. Claudin-18.2 as a therapeutic target in cancers: cumulative findings from basic research and clinical trials. Tissue Barriers. 2022 Jan 2;10(1):1967080. doi: 10.1080/21688370.2021.1967080. Epub 2021 Sep 5.
PubMed 34486479

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 Gastric Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study of Cord Blood-Derived CAR-NK Cells Targeting Claudin18.2 in the Treatment of Advanced Gastric Cancer and Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT06464965
Acronym / sponsor ID: 2024-105
Conditions: Gastric Cancer, Pancreas Adenocarcinoma
Keywords: Gastric Cancer, Pancreatic Adenocarcinoma, CAR-NK, Claudin18.2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Zhejiang Provincial People's HospitalUniversity, hospital or other
Collaborators: Second Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou RongGu Biotechnology Limited Company
Study start: 3 Jul 2024 (actual)
Primary completion: 10 Oct 2025 (actual)
Study completion: 30 Dec 2025 (actual)
First posted: 18 Jun 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.

To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;

Study design

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

Arm	Type	Receives
CB CAR-NK182 Dose Escalation	Experimental	Biological: CB CAR-NK18.2, Drug: Cyclophosphamide, Drug: FludarabineParticipants will receive a lymphodepleting conditioning regimen (FC regimen) followed by three intravenous infusions of Claudin18.2-targeted umbilical cord blood-derived CAR-NK cells (CB CAR-NK182) on days 0, 3, and 7. The study follows a "3+3" dose-escalation design with three planned dose levels. Three dose levels: Dose Level 1 (2×10⁶ cells/kg/infusion on days 0, 3, and 7), Dose Level 2 (8×10⁶ cells/kg/infusion on days 0, 3, and 7), Dose Level 3 (16×10⁶ cells/kg/infusion on days 0, 3, and 7). 3-6 subjects will be enrolled per dose level. Each subject will be observed for at least 28 days after the first infusion, with a long-term follow-up period of 2 years post-first infusion. Standard "3+3" rules apply for DLT observation and dose escalation decisions.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female aged 18-75 years (inclusive);
Understands and voluntarily signs a written informed consent form, and is willing and able to comply with all trial requirements;
Patients with advanced gastric cancer and advanced pancreatic cancer confirmed by histopathology or cytology, who have failed standard treatment or cannot tolerate standard treatment, including but not limited to: pancreatic cancer and gastric cancer;
Immunohistochemical (IHC) detection of CLDN18.2, the positive expression of CLDN18.2 in tumors must be ≥ 10%;
At least 1 measurable lesion according to RECIST 1.1;

Key exclusion criteria (12 listed)

History of other tumors;
Patients who have received CAR-T,CAR-NK,TCR-T and other cell therapy targeting Claudin18.2 within 3 months before study treatment;
Patients with hypersensitivity to cell therapy or any related drugs;
Active autoimmune diseases;
Active infections that cannot be controlled;

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
CB CAR-NK18.2Administered via intravenous infusion on Days 0, 3, and 7. Three dose levels are planned: Dose Level 1: 2×10^6 cells/kg/infusion Dose Level 2: 8×10^6 cells/kg/infusion Dose Level 3: 16×10^6 cells/kg/infusion	Biological	CB CAR-NK182 Dose Escalation
CyclophosphamidePart of the lymphodepletion regimen. Administered at 500 mg/m^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.	Drug	CB CAR-NK182 Dose Escalation
FludarabinePart of the lymphodepletion regimen. Administered at 30 mg/m^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.	Drug	CB CAR-NK182 Dose Escalation

Primary outcome

MTD
Time frame: 1 month
Maximum Tolerated Dose
DLT
Time frame: 1 month
Dose-Dependent Toxicity

5 secondary outcomes

ORR
Time frame: 3 years
DCR
Time frame: 3 years
PFS
Time frame: 3 years
OS
Time frame: 3 years
DOR
Time frame: 3 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
Background: PubMed 28028664Fanotto V, Cordio S, Pasquini G, Fontanella C, Rimassa L, Leone F, Rosati G, Santini D, Giampieri R, Di Donato S, Tomasello G, Silvestris N, Pietrantonio F, Battaglin F, Avallone A, Scartozzi M, Lutrino ES, Melisi D, Antonuzzo L, Pellegrino A, Torri V, Aprile G. Prognostic factors in 868 advanced gastric cancer patients treated with second-line chemotherapy in the real world. Gastric Cancer. 2017 Sep;20(5):825-833. doi: 10.1007/s10120-016-0681-6. Epub 2016 Dec 27.
Background: PubMed 30217672Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Cheng K, Song C, Wu H, Eng-Wong J, Kim K, Kang YK. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018 Oct;19(10):1372-1384. doi: 10.1016/S1470-2045(18)30481-9. Epub 2018 Sep 11.
Background: PubMed 28343975Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.
Background: PubMed 20728210Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
Background: PubMed 23412098Heinemann V, Ebert MP, Laubender RP, Bevan P, Mala C, Boeck S. Phase II randomised proof-of-concept study of the urokinase inhibitor upamostat (WX-671) in combination with gemcitabine compared with gemcitabine alone in patients with non-resectable, locally advanced pancreatic cancer. Br J Cancer. 2013 Mar 5;108(4):766-70. doi: 10.1038/bjc.2013.62. Epub 2013 Feb 14.
Background: PubMed 37055515Cappell KM, Kochenderfer JN. Long-term outcomes following CAR T cell therapy: what we know so far. Nat Rev Clin Oncol. 2023 Jun;20(6):359-371. doi: 10.1038/s41571-023-00754-1. Epub 2023 Apr 13.
Background: PubMed 37566723Khawar MB, Gao G, Rafiq M, Shehzadi A, Afzal A, Abbasi MH, Sheikh N, Afzal N, Ashraf MA, Hamid SE, Shahzaman S, Kawish N, Sun H. Breaking down barriers: The potential of smarter CAR-engineered NK cells against solid tumors. J Cell Biochem. 2023 Aug;124(8):1082-1104. doi: 10.1002/jcb.30460. Epub 2023 Aug 11.
Background: PubMed 31861759Gowrikumar S, Singh AB, Dhawan P. Role of Claudin Proteins in Regulating Cancer Stem Cells and Chemoresistance-Potential Implication in Disease Prognosis and Therapy. Int J Mol Sci. 2019 Dec 20;21(1):53. doi: 10.3390/ijms21010053.
Background: PubMed 34486479Kyuno D, Takasawa A, Takasawa K, Ono Y, Aoyama T, Magara K, Nakamori Y, Takemasa I, Osanai M. Claudin-18.2 as a therapeutic target in cancers: cumulative findings from basic research and clinical trials. Tissue Barriers. 2022 Jan 2;10(1):1967080. doi: 10.1080/21688370.2021.1967080. Epub 2021 Sep 5.
Individual participant dataSharing planned: No

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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.

Yang Liu, M.D. principal investigator

Zhejiang Provincial People's Hospital

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CB CAR-NK18.2, Cyclophosphamide and Fludarabine in people with Gastric Cancer and Pancreas Adenocarcinoma, run by Zhejiang Provincial People's Hospital at 1 site in China.

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 12 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: finished, as of the sponsor's last update on 9 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 China. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

MTD (time frame: 1 month). The study lists 2 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 NCT06464965, which also lists 10 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 9 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.