Ovarian Neoplasms MalignantPhase 1/2NCT07435701
Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites
A Phase 1/2 study testing SK-NK Cell Injection in people with Ovarian Neoplasms Malignant and Ascites, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms Malignant, Ascites
- What is being tested?
- SK-NK Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2026to 31 Dec 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up.
- Female, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons .
- Complicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.
- Expected survival time ≥ 3 months.
- Adequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as:
- Neutrophils (ANC) ≥ 1.0×10^9/L Platelets (PLT) ≥ 80×10^9/L Hemoglobin (Hb) ≥ 80 g/L Total Bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome or liver metastasis) ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis is present) INR ≤ 1.5×ULN and APTT ≤ 1.5×ULN (unless on anticoagulant therapy) Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula) Toxicities from prior therapies must have recovered to ≤ Grade 1 (except for alopecia and ≤ Grade 2 neurotoxicity caused by chemotherapy) .
Who cannot join
- Prior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion.
- Receipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion.
- Receipt of systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed).
- Major surgery within 4 weeks prior to screening or planned major surgery during the study period.
- History of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer).
- History of active or suspected autoimmune or inflammatory disease. History of organ transplantation or hematopoietic stem cell transplantation.
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- Presence of active infection, including:
- Active Hepatitis B (HBsAg positive and HBV-DNA > 1000 copies/mL) Active Hepatitis C (HCV antibody positive and HCV-RNA detected) Systemic active infection requiring antibiotic treatment Congenital or acquired immunodeficiency (e.g., HIV infection) Vaccination with live or attenuated vaccines within 4 weeks prior to intraperitoneal perfusion.
- Severe cardiovascular diseases, including:
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg) History of hypertensive crisis or hypertensive encephalopathy Cardiovascular accident, TIA, myocardial infarction, unstable angina, or significant vascular disease within 6 months NYHA Class ≥ II heart failure or LVEF < 50% Severe arrhythmia uncontrolled by medication (QTc ≥ 450 ms for males, ≥ 470 ms for females), or congenital Long QT syndrome Severe respiratory disease (e.g., history of severe interstitial lung disease, severe COPD), FEV1 < 2L, or DLCO < 40%.
- History of clear neurological or psychiatric disorders, including epilepsy or dementia.
- Other conditions considered unsuitable for the study by the investigator (e.g., prior Grade ≥ 3 adverse events from immunotherapy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD, 8610-87787210, cancergcp@163.com
Ning Li, MD
About this study
Official title: A Single-Arm, Open-Label Phase I/II Clinical Trial of Intraperitoneal Perfusion of SK-NK Cell Injection for the Treatment of Advanced Ovarian Cancer Patients With Massive Ascites
This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites .
The study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity .
Read more
The study consists of two phases:
Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a "3+3" design with three increasing dose levels.
Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D.
Participants will receive the study treatment once weekly for 4 weeks.
Read the detailed description
Background and Rationale:
Ovarian cancer often presents with malignant ascites in advanced stages, which is associated with poor prognosis and severely reduced quality of life. The peritoneal cavity in these patients is characterized by an immunosuppressive tumor microenvironment. Natural Killer (NK) cells are innate immune effector cells capable of recognizing and killing tumor cells without MHC restriction. "Super Kill-NK" (SK-NK) cells are highly activated allogeneic NK cells derived from healthy donors, characterized by high expression of activation markers (e.g., CD16, NKG2D) and enhanced cytotoxicity. Intraperitoneal delivery allows for direct contact between effector cells and tumor cells within the peritoneal cavity, potentially increasing local therapeutic concentration while minimizing systemic toxicity .
Study Design:
This is an open-label, single-arm, Phase I/II study. Phase I (Dose Escalation): Utilizing a standard "3+3" design to assess safety and identify the Dose-Limiting Toxicity (DLT). Three dose cohorts are planned: 3×10^8, 6×10^8, and 9×10^8 cells per dose. The DLT observation period is 28 days after the first infusion.
Phase II (Dose Expansion): Once the Recommended Phase 2 Dose (RP2D) is determined, additional patients will be enrolled to evaluate efficacy.
Intervention:
Eligible patients will receive SK-NK Cell Injection via intraperitoneal perfusion. The treatment schedule consists of one infusion every week for a total of 4 doses (Days 1, 8, 15, and 22).
Objectives:
Primary: To evaluate safety, tolerability, and determine the RP2D. Secondary: To assess the Ascites Response Rate, Objective Response Rate (ORR), Duration of Relief (DoR), and 1-year Overall Survival (OS). Pharmacokinetics (PK) and pharmacodynamics (PD) will also be evaluated by monitoring SK-NK cell persistence and cytokine levels in peripheral blood and ascites .
Exploratory: To investigate the mechanism of action of NK cell therapy in the malignant ascites microenvironment.
- Conditions
- Ovarian Neoplasms Malignant, Ascites
- Being tested
- SK-NK Cell Injection
- Keywords
- SK-NK Cell Injection, Natural Killer Cells, NK Cell Therapy, Intraperitoneal Perfusion, Adoptive Immunotherapy, Immunotherapy, Massive Ascites
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-NK Cell InjectionBiological
Also called Super Kill-NK Cell Injection, Allogeneic NK Cell Injection
Administered via intraperitoneal perfusion. Phase I involves a "3+3" dose escalation with three cohorts: 3x10^8, 6x10^8, and 9x10^8 cells. Phase II uses the Recommended Phase 2 Dose (RP2D). The treatment schedule consists of one infusion weekly for 4 weeks (Days 1, 8, 15, and 22). The product is characterized by high purity (>99%) and high expression of activation markers.
| Study group | Role | What they receive |
|---|---|---|
| SK-NK Cell Injection | Experimental | Participants receive SK-NK Cell Injection via intraperitoneal perfusion. Phase I follows a "3+3" dose-escalation design with three cohorts (3*10^8, 6*10^8, and 9*10^8 cells). Phase II operates at the Recommended Phase 2 Dose (RP2D). Treatment is administered once weekly for 4 weeks (Days 1, 8, 15, and 22). Receives: Biological: SK-NK Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Dose-Limiting Toxicities
Number of participants experiencing TEAEs and DLTs. Safety is evaluated using NCI CTCAE v5.0 and ASTCT consensus for CRS.
Measured: From baseline up to 28 days post-infusion for DLT; safety follow-up through study completion (approx. 1 year)
RP2D
To determine the optimal dose for the Phase II expansion phase based on the evaluation of DLTs and the overall safety profile observed in the dose-escalation cohorts.
Measured: Up to approximately 28 days after the first dose of the last participant in the dose-escalation phase.
Secondary outcomes (7)
Ascites Response Rate
Defined as the proportion of participants who require no paracentesis (abdominal drainage) for at least 4 weeks and whose ascites volume (measured by ultrasound as average depth x 10 x abdominal circumference) is controlled at Day 29.
Measured: At Day 29 (±3 days) post-treatment initiation
Objective Response Rate (ORR)
Defined as the percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) after intraperitoneal perfusion.
Measured: Assessed periodically up to approximately 1 year
Ascites Symptom Improvement Rate
Defined as the proportion of participants whose malignant ascites symptom scale score decreases by ≥30% compared to baseline.
Measured: Assessed periodically up to approximately 1 year
Duration of Ascites Relief (DoR)
Defined as the time from the first documentation of objective response (CR or PR) to the first documented disease progression or death from any cause.
Measured: From date of first response until progression or death, assessed up to approx. 1 year
1-Year Overall Survival (OS) Rate
Defined as the percentage of participants who are alive at 1 year after the initiation of treatment.
Measured: 1 year post-treatment initiation
Persistence of SK-NK Cells in Peripheral Blood
Measured by qPCR to detect specific DNA sequences in peripheral blood samples.
Measured: At Days 1, 8, 15, 22, and 29 during the treatment phase
Persistence of SK-NK Cells in Ascites
Measured by qPCR to detect specific DNA sequences in ascites samples.
Measured: At Days 1, 8, 15, 22, and 29 during the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Jan 2026
- Primary completion23 Jan 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I utilizes a standard "3+3" dose-escalation design with three dose levels (3x10\^8, 6x10\^8, 9x10\^8 cells). Phase II is a dose-expansion phase at the Recommended Phase 2 Dose (RP2D) to further evaluate efficacy and safety.
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cells First Biotechnology (Beijing) Co., Ltd
- Responsible party
- Principal investigator, NING LI-GYN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ning Li, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435701
- Sponsor's protocol ID
- NCC5843
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this study (text, tables, figures, and appendices) will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Phase I/II Clinical Trial of Intraperitoneal Perfusion of SK-NK Cell Injection for the Treatment of Advanced Ovarian Cancer Patients With Massive Ascites
- ClinicalTrials.gov ID
- NCT07435701
- Acronym / sponsor ID
- NCC5843
- Conditions
- Ovarian Neoplasms Malignant, Ascites
- Keywords
- SK-NK Cell Injection, Natural Killer Cells, NK Cell Therapy, Intraperitoneal Perfusion, Adoptive Immunotherapy, Immunotherapy, Massive Ascites
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cells First Biotechnology (Beijing) Co., Ltd
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (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 single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites .
The study focuses on patients who have failed standard therapies and are suffering from severe ascites. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity .
The study consists of two phases:
Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a "3+3" design with three increasing dose levels.
Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D.
Participants will receive the study treatment once weekly for 4 weeks.
Detailed description
Background and Rationale:
Ovarian cancer often presents with malignant ascites in advanced stages, which is associated with poor prognosis and severely reduced quality of life. The peritoneal cavity in these patients is characterized by an immunosuppressive tumor microenvironment. Natural Killer (NK) cells are innate immune effector cells capable of recognizing and killing tumor cells without MHC restriction. "Super Kill-NK" (SK-NK) cells are highly activated allogeneic NK cells derived from healthy donors, characterized by high expression of activation markers (e.g., CD16, NKG2D) and enhanced cytotoxicity. Intraperitoneal delivery allows for direct contact between effector cells and tumor cells within the peritoneal cavity, potentially increasing local therapeutic concentration while minimizing systemic toxicity .
Study Design:
This is an open-label, single-arm, Phase I/II study. Phase I (Dose Escalation): Utilizing a standard "3+3" design to assess safety and identify the Dose-Limiting Toxicity (DLT). Three dose cohorts are planned: 3×10^8, 6×10^8, and 9×10^8 cells per dose. The DLT observation period is 28 days after the first infusion.
Phase II (Dose Expansion): Once the Recommended Phase 2 Dose (RP2D) is determined, additional patients will be enrolled to evaluate efficacy.
Intervention:
Eligible patients will receive SK-NK Cell Injection via intraperitoneal perfusion. The treatment schedule consists of one infusion every week for a total of 4 doses (Days 1, 8, 15, and 22).
Objectives:
Primary: To evaluate safety, tolerability, and determine the RP2D. Secondary: To assess the Ascites Response Rate, Objective Response Rate (ORR), Duration of Relief (DoR), and 1-year Overall Survival (OS). Pharmacokinetics (PK) and pharmacodynamics (PD) will also be evaluated by monitoring SK-NK cell persistence and cytokine levels in peripheral blood and ascites .
Exploratory: To investigate the mechanism of action of NK cell therapy in the malignant ascites microenvironment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I utilizes a standard "3+3" dose-escalation design with three dose levels (3x10^8, 6x10^8, 9x10^8 cells). Phase II is a dose-expansion phase at the Recommended Phase 2 Dose (RP2D) to further evaluate efficacy and safety.
| Arm | Type | Receives |
|---|---|---|
| SK-NK Cell Injection | Experimental | Biological: SK-NK Cell InjectionParticipants receive SK-NK Cell Injection via intraperitoneal perfusion. Phase I follows a "3+3" dose-escalation design with three cohorts (3*10^8, 6*10^8, and 9*10^8 cells). Phase II operates at the Recommended Phase 2 Dose (RP2D). Treatment is administered once weekly for 4 weeks (Days 1, 8, 15, and 22). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up.
- Female, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons .
- Complicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT.
- Expected survival time ≥ 3 months.
- Adequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as:
Key exclusion criteria (12 listed)
- Prior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion.
- Receipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion.
- Receipt of systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed).
- Major surgery within 4 weeks prior to screening or planned major surgery during the study period.
- History of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer).
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 |
|---|---|---|
| SK-NK Cell InjectionAlso: Super Kill-NK Cell Injection, Allogeneic NK Cell InjectionAdministered via intraperitoneal perfusion. Phase I involves a "3+3" dose escalation with three cohorts: 3x10^8, 6x10^8, and 9x10^8 cells. Phase II uses the Recommended Phase 2 Dose (RP2D). The treatment schedule consists of one infusion weekly for 4 weeks (Days 1, 8, 15, and 22). The product is characterized by high purity (>99%) and high expression of activation markers. | Biological | SK-NK Cell Injection |
Primary outcome
Incidence of Adverse Events and Dose-Limiting Toxicities
Time frame: From baseline up to 28 days post-infusion for DLT; safety follow-up through study completion (approx. 1 year)
Number of participants experiencing TEAEs and DLTs. Safety is evaluated using NCI CTCAE v5.0 and ASTCT consensus for CRS.
RP2D
Time frame: Up to approximately 28 days after the first dose of the last participant in the dose-escalation phase.
To determine the optimal dose for the Phase II expansion phase based on the evaluation of DLTs and the overall safety profile observed in the dose-escalation cohorts.
7 secondary outcomes
Ascites Response Rate
Time frame: At Day 29 (±3 days) post-treatment initiation
Objective Response Rate (ORR)
Time frame: Assessed periodically up to approximately 1 year
Ascites Symptom Improvement Rate
Time frame: Assessed periodically up to approximately 1 year
Duration of Ascites Relief (DoR)
Time frame: From date of first response until progression or death, assessed up to approx. 1 year
1-Year Overall Survival (OS) Rate
Time frame: 1 year post-treatment initiation
Persistence of SK-NK Cells in Peripheral Blood
Time frame: At Days 1, 8, 15, 22, and 29 during the treatment phase
Persistence of SK-NK Cells in Ascites
Time frame: At Days 1, 8, 15, 22, and 29 during the treatment phase
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 17 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this study (text, tables, figures, and appendices) will be made available.
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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.
Ning Li, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SK-NK Cell Injection in people with Ovarian Neoplasms Malignant and Ascites, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 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: looking for participants now, as of the sponsor's last update on 17 Mar 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 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 Ning Li, MD (8610-87787211, liningnci@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and Dose-Limiting Toxicities (time frame: From baseline up to 28 days post-infusion for DLT; safety follow-up through study completion (approx. 1 year)). 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?
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 17 Mar 2026.