Ovary CancerPhase 1/2NCT07096583
An Exploratory Study on NK Cell-assisted Prevention of Bone Marrow Suppression During Chemotherapy for Ovarian Cancer
A Phase 1/2 study testing METR-NK cell（metabolic remodeling nature killer cells） in people with Ovary Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
To evaluate the remission effect and safety of intravenous injection of METR-NK cells as adjuvant therapy on bone marrow suppression in patients with ovarian cancer after chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovary 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2025to 30 Jul 2027
- 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);
- Confirmed by pathology of high grade serous ovarian cancer, high level of endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer;
- ECOG score: 0-1;
- before, during, and after treatment of blood specimen can obtain, and the participants agreed to expand blood samples to central laboratory for the trial research purposes.;
- Expectations alive at least 3 months;
- Laboratory examination indexes meet the following requirements
Show all 11Show fewer
- (1) renal function: Cr ULN or less (upper limit of normal) x 1.5, endogenous creatinine clearance rate (Ccr) or 60 ml/min;
- (2) the liver function: the total bilirubin ULN x 1.5 or less; ALT and AST≤ULN×2.5; (If there is intrahepatic cholangiocarcinoma or liver metastasis, the total bilirubin level should be less than 3 times the upper limit of normal, and the aminotransferase level should be less than 5 times the upper limit of normal); The neutrophilic granulocyte count
- Women of childbearing age agreed to during the study and research within 6 months after the end of contraception, And non-lactating patients;
- Participants can understand the research situation and voluntarily signed informed consent. No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃;
- Expected, adherence to the good curative effect and adverse reaction will be effected according to the plan calls for follow-up
Who cannot join
- Patients had received drugs that were in other clinical trials or other cellular immunotherapies within 28 days before the screening period;
- Patients with other malignant tumours in the past five years.;
- Acute illness is ongoing, or in the past 2 years with severe disease, such as active infection, cardiovascular disease or fever patients heart function (grade III or IV level), mental health problems (such as alcohol, drugs).;
- Immunodeficiency disease, including HIV positive or suffering from other acquired and congenital immunodeficiency disease;
- Organ transplantation, organ transplantation or organ failure patients undergoing immunosuppressive medication or long-term use of immunosuppressive drugs patients;
- Move/vein thrombosis incidents happened in 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
Show all 10Show fewer
- In patients with known to METR NK preparation any component of the final product, including the human serum albumin;
- Breastfeeding during screening serum or urine pregnancy test was positive in female;
- subjects suffering from mental illness, including major depression, mania, epilepsy, dementia, etc;
- Researchers say the other condition that doesn't fit into the group.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the remission effect and safety of intravenous injection of METR-NK cells as adjuvant therapy on bone marrow suppression in patients with ovarian cancer after chemotherapy
Read the detailed description
100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.
- Conditions
- Ovary 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）Biological
100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| METR-NK cell（metabolic remodeling nature killer cells） | Experimental | 100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy. Receives: Biological: 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.
The remission rate of bone marrow suppression
The objective of the study was to evaluate the efficacy and safety of NK cell adjuvant therapy in alleviating chemotherapy-induced myelosuppression in patients with ovarian cancer. The primary endpoints included the time to neutrophil recovery, the improvement rate of platelet count, and the incidence of infectious events
Measured: 3-month
Secondary outcomes (1)
Adverse event
Any adverse medical event that occurred after the subject received the trial drug
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start7 Jul 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary 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
- 20 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
- NCT07096583
- Sponsor's protocol ID
- 2025-LLYJ-0036
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on NK Cell-assisted Prevention of Bone Marrow Suppression During Chemotherapy for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07096583
- Acronym / sponsor ID
- 2025-LLYJ-0036
- Conditions
- Ovary Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Collaborators
- Anhui Kecheng intelligent health technology Co., LTD
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 31 Jul 2025 (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 remission effect and safety of intravenous injection of METR-NK cells as adjuvant therapy on bone marrow suppression in patients with ovarian cancer after chemotherapy
Detailed description
100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.
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 | Biological: METR-NK cell（metabolic remodeling nature killer cells）100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-70 years old (≥18, ≤70);
- Confirmed by pathology of high grade serous ovarian cancer, high level of endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer;
- ECOG score: 0-1;
- before, during, and after treatment of blood specimen can obtain, and the participants agreed to expand blood samples to central laboratory for the trial research purposes.;
- Expectations alive at least 3 months;
Key exclusion criteria (10 listed)
- Patients had received drugs that were in other clinical trials or other cellular immunotherapies within 28 days before the screening period;
- Patients with other malignant tumours in the past five years.;
- Acute illness is ongoing, or in the past 2 years with severe disease, such as active infection, cardiovascular disease or fever patients heart function (grade III or IV level), mental health problems (such as alcohol, drugs).;
- Immunodeficiency disease, including HIV positive or suffering from other acquired and congenital immunodeficiency disease;
- Organ transplantation, organ transplantation or organ failure patients undergoing immunosuppressive medication or long-term use of immunosuppressive drugs patients;
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）100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy. | Biological | METR-NK cell（metabolic remodeling nature killer cells） |
Primary outcome
The remission rate of bone marrow suppression
Time frame: 3-month
The objective of the study was to evaluate the efficacy and safety of NK cell adjuvant therapy in alleviating chemotherapy-induced myelosuppression in patients with ovarian cancer. The primary endpoints included the time to neutrophil recovery, the improvement rate of platelet count, and the incidence of infectious events
1 secondary outcome
Adverse event
Time frame: 12-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 31 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Ovary Cancer
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma
Enrolling by invitationPhase 1/2
Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors
Ovarian Cancer
Active, not recruitingPhase 2
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ovary 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 11 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. 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?
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?
The remission rate of bone marrow suppression (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 31 Jul 2025.