HRD-negative Epithelial Ovarian CancerYS247NCT07455071
A Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Study Participants With HRD-negative Epithelial Ovarian Cancer
A study testing Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247) in people with HRD-negative Epithelial Ovarian Cancer, run by Peking University Third Hospital.
Trial summary
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated exploratory study designed to evaluate the safety, tolerability and preliminary efficacy of tumor neoantigen-pulsed autologous dendritic cell injection (YS247) in participants with HRD-negative epithelial ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HRD-negative Epithelial Ovarian Cancer
- What is being tested?
- Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Nov 2027
- Phase
- Interventional
- 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
- Female aged 18-70 years (inclusive of cut-off values); body weight ≥45 kg.
- Failed to achieve Complete Response (CR) after completion of at least first-line therapy (i.e., surgery and platinum-based chemotherapy), with abnormal CA125 levels or at least one measurable lesion confirmed by imaging assessment.
- Completed genomic and transcriptomic sequencing of tumor samples, finished the analysis of genetic mutation characteristics and immune characteristics of tumor samples, and is eligible for screening of personalized tumor neoantigens.
- Laboratory examinations must meet the following criteria: white blood cell count ≥4.0×10⁹/L; absolute lymphocyte count ≥1.0×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥9.0 g/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×Upper Limit of Normal (ULN) (≤5×ULN for patients with concurrent liver metastases); bilirubin ≤1.5×ULN (≤3×ULN for patients with Gilbert's syndrome); alkaline phosphatase (ALP) ≤2.5×ULN (≤5×ULN for patients with concurrent liver metastases); albumin ≥30 g/L; serum creatinine and/or urea <1.5 times the normal value; coagulation tests: international normalized ratio (INR) <1.7 or prolonged prothrombin time (PT) <4 seconds.
- 12-lead electrocardiogram (ECG) must meet the following criteria: no severe arrhythmia, QTcF ≤480 ms.
- Toxic and adverse reactions induced by previous treatments must have recovered to Grade ≤1 (per NCI-CTCAE v5.0), with the exception of stable Grade 2 sensory neuropathy or alopecia (per CTCAE).
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- With patent vascular access and capable of undergoing peripheral blood mononuclear cell (PBMC) collection.
- Expected survival time >6 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 (see Appendix 2).
- Fertile study participants must agree to adopt medically effective contraceptive measures throughout the trial period and for at least 6 months after the last administration; fertile study participants must have a negative pregnancy test result within 28 days prior to enrollment and at baseline.
- Study participants are able to understand the trial procedures, are willing to comply with the clinical trial protocol to complete the trial, and have signed the informed consent form (ICF).
Who cannot join
- (Per interview) Allergic diathesis with hypersensitivity to two or more drugs, or known hypersensitivity to any component of the personalized neoantigen-sensitized autologous dendritic cell injection (cell cryopreservation solution CS10, human albumin, 0.9% sodium chloride injection).
- (Per interview) A past or current diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).
- (Per interview) Patients with symptomatic, uncontrolled brain metastasis or leptomeningeal metastasis.
- (Per interview) Suffering from severe or uncontrolled diseases, including but not limited to: uncontrolled ventricular arrhythmia, myocardial infarction within the recent 3 months, uncontrolled grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome, immunodeficiency (excluding splenectomy), or other diseases that the investigator deems may expose the patient to a high risk of harm.
- Positive for Human Immunodeficiency Virus (HIV) antibody, Treponema Pallidum (TP) antibody, or Hepatitis C Virus (HCV) antibody; or evidence of active hepatitis B via Hepatitis B Virus (HBV) surface antigen/HBV DNA testing.
- New York Heart Association (NYHA) Grade III-IV congestive heart failure, or clinically significant arrhythmia with poor control.
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- Uncontrolled arterial hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
- (Per interview) A history of or current comorbidities including the following:a) Autoimmune disease requiring long-term (more than 2 months) systemic immunosuppressant (corticosteroid) therapy, or immune-mediated symptomatic diseases (including ulcerative colitis, Crohn's disease, rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), autoimmune vasculitis (e.g., Wegener's granulomatosis));b) A past diagnosis of immune-mediated motor neuron disease;c) A past diagnosis of Toxic Epidermal Necrolysis (TEN);d) Any psychiatric disorder (including dementia, altered mental status) that may impair the understanding and completion of informed consent and relevant questionnaires;e) Long-term use of non-inhaled corticosteroids, hydroxyurea, or immunomodulatory drugs;f) A history of other active malignant tumors within the past 5 years (excluding patients with basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast that have been completely cured and require no follow-up treatment);g) Hypothyroidism (patients with hypothyroidism requiring only thyroid hormone replacement therapy are eligible for enrollment).
- (Per interview) Judged by the investigator as unsuitable for enrollment or unable to comply with the protocol requirements, including but not limited to: persistent fever (>24 h) documented by repeated measurements or due to active, uncontrolled infection from screening to prior to drug administration.
- (Per interview) Receipt of cellular immunotherapy within the past 6 months (including: Cytokine-Induced Killer (CIK) cells, dendritic cell (DC) therapy, DC-CIK therapy, Lymphokine-Activated Killer (LAK) cells, and other cellular immunotherapies).
- In addition to the above requirements, patients who meet any of the following criteria shall also be excluded prior to the collection of autologous peripheral blood mononuclear cells (PBMCs):
- Receipt of platelet or red blood cell transfusion within 3 weeks prior to collection.
- Receipt of chemotherapy within 3 weeks prior to collection.
- Receipt of anti-angiogenic tyrosine kinase inhibitor (TKI) small-molecule drugs within 3 weeks prior to collection.
- Use of corticosteroids (or analogs) or systemic administration of immunomodulatory therapies within 3 weeks prior to collection.
- Participation in a clinical study of an investigational non-biolgical product (administered within the past 30 days or 5 half-lives, whichever is longer) or an investigational biological product (monoclonal or polyclonal antibodies) (administered within the past 4 months or 5 half-lives, whichever is longer) prior to screening.
- Pregnant or lactating female study participants.
- Study participants with insufficient sensitivity to immunotherapy as determined by tumor genetic analysis.
- Study participants who are judged by the investigator as unable to adhere to the trial procedures, or deemed ineligible for enrollment for any other reason.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Investigator Initiated Clinical Study of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in the Treatment of Patients With HRD-negative Epithelial Ovarian Cancer
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated exploratory study designed to evaluate the safety, tolerability and preliminary efficacy of tumor neoantigen-pulsed autologous dendritic cell injection (YS247) in participants with HRD-negative epithelial ovarian cancer.
Read the detailed description
A total of 9 to 18 participants are planned to be enrolled in this study. A dose-escalation design will be adopted following the 3+3 escalation principle, and the injection dose of the study drug YS247 is preset at three dose levels (low, medium, high) as specified below, with 3 to 6 participants planned to be enrolled in each dose level group. An adaptive trial design will be implemented, where the number of enrolled participants in each group will be adjusted based on the actual clinical study results
- Conditions
- HRD-negative Epithelial Ovarian Cancer
- Being tested
- Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)
- Keywords
- tumor neoantigen, autologous dentritic cell, HRD-negative epithelial ovarian cancer, ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)Biological
Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)
| Study group | Role | What they receive |
|---|---|---|
| Adhering to the 3+3 dose escalation principle, a dose escalation design will be adopted | Experimental | Adhering to the 3+3 dose escalation principle, a dose escalation design will be adopted. Three dose levels (low, medium, and high) are preset for the injection dose of the investigational product YS247, with 3 to 6 study subjects planned to be enrolled in each dose cohort. An adaptive trial design will be implemented, and the number of enrolled subjects in each cohort will be adjusted based on the actual results of the clinical study。 Each study subject will receive a total of 8 treatment cycles (8 administrations). For each administration, YS247 may be delivered via a maximum of 3 injection sites, with a maximum volume of 0.3 mL of YS247 injected per site. Receives: Biological: Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of YS247 in study participants with HRD-negative epithelial ovarian cancer, and to determine the Maximum Tolerated Dose (MTD) / Recommended Expansion Dose.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HRD-negative Epithelial 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Rong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455071
- Sponsor's protocol ID
- M20250115
- Acronym
- YS247
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Clinical Study of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in the Treatment of Patients With HRD-negative Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07455071
- Acronym / sponsor ID
- YS247 / M20250115
- Conditions
- HRD-negative Epithelial Ovarian Cancer
- Keywords
- tumor neoantigen, autologous dentritic cell, HRD-negative epithelial ovarian cancer, ovarian cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 Mar 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, dose-escalation, multiple-dose investigator-initiated exploratory study designed to evaluate the safety, tolerability and preliminary efficacy of tumor neoantigen-pulsed autologous dendritic cell injection (YS247) in participants with HRD-negative epithelial ovarian cancer.
Detailed description
A total of 9 to 18 participants are planned to be enrolled in this study. A dose-escalation design will be adopted following the 3+3 escalation principle, and the injection dose of the study drug YS247 is preset at three dose levels (low, medium, high) as specified below, with 3 to 6 participants planned to be enrolled in each dose level group. An adaptive trial design will be implemented, where the number of enrolled participants in each group will be adjusted based on the actual clinical study results
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adhering to the 3+3 dose escalation principle, a dose escalation design will be adopted | Experimental | Biological: Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)Adhering to the 3+3 dose escalation principle, a dose escalation design will be adopted. Three dose levels (low, medium, and high) are preset for the injection dose of the investigational product YS247, with 3 to 6 study subjects planned to be enrolled in each dose cohort. An adaptive trial design will be implemented, and the number of enrolled subjects in each cohort will be adjusted based on the actual results of the clinical study。 Each study subject will receive a total of 8 treatment cycles (8 administrations). For each administration, YS247 may be delivered via a maximum of 3 injection sites, with a maximum volume of 0.3 mL of YS247 injected per site. |
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)
- Female aged 18-70 years (inclusive of cut-off values); body weight ≥45 kg.
- Failed to achieve Complete Response (CR) after completion of at least first-line therapy (i.e., surgery and platinum-based chemotherapy), with abnormal CA125 levels or at least one measurable lesion confirmed by imaging assessment.
- Completed genomic and transcriptomic sequencing of tumor samples, finished the analysis of genetic mutation characteristics and immune characteristics of tumor samples, and is eligible for screening of personalized tumor neoantigens.
- Laboratory examinations must meet the following criteria: white blood cell count ≥4.0×10⁹/L; absolute lymphocyte count ≥1.0×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥9.0 g/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×Upper Limit of Normal (ULN) (≤5×ULN for patients with concurrent liver metastases); bilirubin ≤1.5×ULN (≤3×ULN for patients with Gilbert's syndrome); alkaline phosphatase (ALP) ≤2.5×ULN (≤5×ULN for patients with concurrent liver metastases); albumin ≥30 g/L; serum creatinine and/or urea <1.5 times the normal value; coagulation tests: international normalized ratio (INR) <1.7 or prolonged prothrombin time (PT) <4 seconds.
- 12-lead electrocardiogram (ECG) must meet the following criteria: no severe arrhythmia, QTcF ≤480 ms.
Key exclusion criteria (19 listed)
- (Per interview) Allergic diathesis with hypersensitivity to two or more drugs, or known hypersensitivity to any component of the personalized neoantigen-sensitized autologous dendritic cell injection (cell cryopreservation solution CS10, human albumin, 0.9% sodium chloride injection).
- (Per interview) A past or current diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).
- (Per interview) Patients with symptomatic, uncontrolled brain metastasis or leptomeningeal metastasis.
- (Per interview) Suffering from severe or uncontrolled diseases, including but not limited to: uncontrolled ventricular arrhythmia, myocardial infarction within the recent 3 months, uncontrolled grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome, immunodeficiency (excluding splenectomy), or other diseases that the investigator deems may expose the patient to a high risk of harm.
- Positive for Human Immunodeficiency Virus (HIV) antibody, Treponema Pallidum (TP) antibody, or Hepatitis C Virus (HCV) antibody; or evidence of active hepatitis B via Hepatitis B Virus (HBV) surface antigen/HBV DNA testing.
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 |
|---|---|---|
| Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247)Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247) | Biological | Adhering to the 3+3 dose escalation principle, a dose escalation design will be adopted |
Primary outcome
Evaluate the safety and tolerability of YS247 in study participants with HRD-negative epithelial ovarian cancer, and to determine the Maximum Tolerated Dose (MTD) / Recommended Expansion Dose.
Time frame: 12 months
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 16 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor Neoantigen-Sensitized Autologous Dendritic Cell Injection (YS247) in people with HRD-negative Epithelial Ovarian Cancer, run by Peking University Third Hospital.
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 19 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Rong li (13701085402, roseli001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of YS247 in study participants with HRD-negative epithelial ovarian cancer, and to determine the Maximum Tolerated Dose (MTD) / Recommended Expansion Dose. (time frame: 12 months). 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 16 Mar 2026.