A Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability and Prelimin… (NCT07455071) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
9 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
. 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).
. With patent vascular access and capable of undergoing peripheral blood mononuclear cell (PBMC) collection.
. Expected survival time \>6 months.
Exclusion criteria
. (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.
. (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).