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.
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.
China1 site, 1 recruiting
- Recruiting
Anhui Cancer Hospital
Hefei, Anhui
Bai-Rong Xia, 18604516165, xiabairong9999@126.com
Yao Chen, 18379859820, 1969354224@qq.com
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 group | Role | What they receive |
|---|---|---|
| METR-NK cell（metabolic remodeling nature killer cells） | Experimental | Intraperitoneal 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.
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)
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
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
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
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
Survival rate
the date of enrollment to the date of death from any cause
Measured: 3-years
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.
- First posted2 May 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- 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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Kecheng intelligent health technology Co., LTD
- Responsible party
- Principal investigator, Bai-Rong Xia, Anhui Provincial Cancer Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06395844
- Acronym / sponsor ID
- 2024 No. 050
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Collaborators
- Anhui Kecheng intelligent health technology Co., LTD
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| METR-NK cell（metabolic remodeling nature killer cells） | Experimental | Drug: METR-NK cell(Metabolic Remodeling Nature Killer Cells)Intraperitoneal 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| METR-NK cell(Metabolic Remodeling Nature Killer Cells)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. | Drug | METR-NK cell（metabolic remodeling nature killer cells） |
Primary outcome
R0 resection rate
Time frame: 3-month
the percentage of patients received R0 resection after METR-NK cells as neoadjuvant therapy for advanced epithelial ovarian cancer
6 secondary outcomes
Overall Response Rate (ORR) After Neoadjuvant treatment
Time frame: 3-month
Pathological complete remission rate
Time frame: 3-month
Disease control rate
Time frame: 3-month
Progression free survival
Time frame: 2-years
Survival rate
Time frame: 3-years
Adverse event
Time frame: 3-month
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 2 May 2024.
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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.
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 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?
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.