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

1. (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).

2. (Per interview) A past or current diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).

3. (Per interview) Patients with symptomatic, uncontrolled brain metastasis or leptomeningeal metastasis.

4. (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.

5. 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.

6. New York Heart Association (NYHA) Grade III-IV congestive heart failure, or clinically significant arrhythmia with poor control.

7. Uncontrolled arterial hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).

8. (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).

9. (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.

10. (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):

11. Receipt of platelet or red blood cell transfusion within 3 weeks prior to collection.

12. Receipt of chemotherapy within 3 weeks prior to collection.

13. Receipt of anti-angiogenic tyrosine kinase inhibitor (TKI) small-molecule drugs within 3 weeks prior to collection.

14. Use of corticosteroids (or analogs) or systemic administration of immunomodulatory therapies within 3 weeks prior to collection.

15. 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.

16. Pregnant or lactating female study participants.

17. Study participants with insufficient sensitivity to immunotherapy as determined by tumor genetic analysis.

18. 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.

What this study is about