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Ovarian CancerPhase 1/2NCT06395844

Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer

A Phase 1/2 study testing METR-NK cell(Metabolic Remodeling Nature Killer Cells) in people with Ovarian Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.

Recruiting

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

Sites and contacts
Official record
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Trial summary

The goal of this type of clinical trial study is to evaluate the safety and efficacy of metabolic remodeling nature killer cells as neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
METR-NK cell(Metabolic Remodeling Nature Killer Cells)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
1 May 2024to 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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-70 years old (≥18, ≤70);
  • Open surgery, laparoscopic surgery, or coarse needle biopsy for histopathological confirmation of advanced (FIGO IIIC/IV stage) high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal carcinoma, and/or fallopian tube carcinoma, etc.;
  • ECOG score: 0-1;
  • Blood and tissue specimens before, during, and after treatment can be obtained, and subjects agree to submit blood and tissue specimens to the central laboratory for the purpose of expanding research in this trial;
  • At least one lesion measurable by CT/MRI according to RECIST 1.1 criteria;
  • Expected survival of at least 3 months;
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  • Patients judged by professional gynecologic oncologists as unable to achieve R0 resection or intolerant to surgery.
  • Criteria for determining inability to achieve R0 resection include but are not limited to: Fagotti laparoscopic score ≥8 points; When laparoscopic evaluation is difficult to implement, an upper abdominal CT score ≥3 points may be used;
  • Criteria for intolerance to surgery may include: Advanced age: age ≥70; Body mass index: BMI ≥40.0; Multiple chronic diseases; Malnutrition or hypoalbuminemia; Moderate to large amount of ascites; Newly diagnosed venous thromboembolism (survival period greater than 12 weeks);
  • Major organ function meets the following criteria within 7 days before treatment: Hematological examination: Hemoglobin ≥90g/L, white blood cell count ≥3×10^9/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥90×10^9/L; Kidney: Serum creatinine <1.5 mg/dL, glomerular filtration rate (GFR) ≥50 ml/min (based on the Fairview Laboratories formula at screening); Liver: AST, ALT, and alkaline phosphatase <3 times the upper limit of normal for the institution, total bilirubin <1.5 times the upper limit of normal for the institution; Lung function: Resting oxygen saturation ≥90%; Cardiac function: Left ventricular ejection fraction (LVEF) ≥40% by echocardiography, MUGA, or cardiac MRI; no evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, or acute ischemia or active conduction system abnormalities on electrocardiography;
  • No history of intestinal obstruction within two months;
  • Reproductive-age patients must take effective contraceptive measures;
  • Subjects voluntarily join this study and sign an informed consent form (ICF);
  • Good compliance is expected, and subjects are able to follow up on efficacy and adverse reactions as required by the protocol.

Who cannot join

  • Patients who have received drugs or other cell immunotherapy in other clinical trials within 28 days before the screening period;
  • Patients who have had other malignant tumors in the past 5 years;
  • Acute illnesses are ongoing, or severe illnesses have occurred in the past 2 years, such as patients with active infections or fever, cardiovascular diseases (Grade III or IV heart failure), mental health issues (such as alcoholism, drug abuse);
  • History of immunodeficiency, including HIV-positive status or other acquired, congenital immunodeficiency diseases;
  • Organ transplant or organ failure patients, patients receiving immunosuppressive therapy after organ transplantation, or patients taking immunosuppressive drugs long-term;
  • Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism within 6 months;
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  • Known allergy to any component of the final product of METR-NK preparation, including human serum albumin;
  • Breastfeeding during the screening period or female subjects with positive serum or urine pregnancy tests;
  • Patients with mental illnesses, including epilepsy, dementia, severe depression, bipolar disorder, etc.;
  • Other conditions deemed unsuitable for inclusion by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bai-Rong Xia contact

18604516165

xiabairong9999@126.com

China1 site, 1 recruiting

  • Anhui Cancer Hospital

    Hefei, Anhui

    Bai-Rong Xia, 18604516165, xiabairong9999@126.com

    Yao Chen, 18379859820, 1969354224@qq.com

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer: A Single-arm, Single-center, Exploratory Clinical Study

The goal of this type of clinical trial study is to evaluate the safety and efficacy of metabolic remodeling nature killer cells as neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer

Read the detailed description

Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells (PBMc) will be isolated and purified for NK manufacturing. The addition of key metabolic molecules in the medium remodeled the metabolic network of NK cells, significantly reduced the aging phenomenon of NK cells in the culture process, improved the cell activity of NK cells and enhanced the cytotoxicity of NK cells. After 14 days cultivation, activated METR-NK will be harvested and formulated for clinical administration.

Conditions
Ovarian Cancer
Being tested
METR-NK cell(Metabolic Remodeling Nature Killer Cells)
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • METR-NK cell(Metabolic Remodeling Nature Killer Cells)Drug

    The minimum amount of METR-NK cells infused each time should be no less than 7.5×10^7 cells, Continuous infusion for 2 days constitutes one course, with 4 courses. The infusion is given every 2 weeks.

Study groups in NCT06395844
Study groupRoleWhat they receive
METR-NK cell（metabolic remodeling nature killer cells）ExperimentalIntraperitoneal allogeneic METR-NK cells infusion ： Dilute 200 mL of METR-NK cells in 1500 mL of 0.9% saline solution at 37°C. The minimum amount of METR-NK cells infused each time should be no less than 7.5×10^7 cells per kilogram. Continuous infusion for 2 days constitutes one course, with 4 courses, with 13-day interval between each course
Receives: Drug: METR-NK cell(Metabolic Remodeling Nature Killer Cells)

What is being measured

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

  1. R0 resection rate

    the percentage of patients received R0 resection after METR-NK cells as neoadjuvant therapy for advanced epithelial ovarian cancer

    Measured: 3-month

Secondary outcomes (6)

  1. Overall Response Rate (ORR) After Neoadjuvant treatment

    Overall Response Rate according to RECIST1.1 after Neoadjuvant treatment. ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

    Measured: 3-month

  2. Pathological complete remission rate

    No residual invasive carcinoma was found under the microscope, but ductal carcinoma in situ could be found; In addition, compare the amount of cancer cells in the specimen before and after the new adjuvant therapy, and use of the Miller Payne grading system to evaluate the effect of the new adjuvant therapy

    Measured: 3-month

  3. Disease control rate

    the percentage of patients with complete response, partial response, and stable disease for more than 4 weeks in which response can be evaluated

    Measured: 3-month

  4. Progression free survival

    the date of enrollment to the date of the first onset of disease progression or death from any cause, whichever comes first

    Measured: 2-years

  5. Survival rate

    the date of enrollment to the date of death from any cause

    Measured: 3-years

  6. Adverse event

    Adverse medical events in clinical trial subjects treated with METR-NK cells

    Measured: 3-month

Timeline

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

  1. First posted2 May 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion31 Dec 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06395844
Sponsor's protocol ID
2024 No. 050
Status last verified
May 2024
First submitted
29 Apr 2024
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing METR-NK cell(Metabolic Remodeling Nature Killer Cells) in people with Ovarian Cancer, run by Anhui Provincial Cancer 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 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 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 Bai-Rong Xia (18604516165, xiabairong9999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: 3-month). 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 NCT06395844.

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 2 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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