Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections for Malignant Solid Tumors

Официальное название

Real-World Study of Personalized Neoantigen-pulsed Autologous Dendritic Cell Injections （ZSNeo-DC ）for Malignant Solid Tumors

Обзор

This is a prospective, single-center, open-label, real-world clinical study designed to evaluate the safety, efficacy, and immunogenicity of Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）in patients with malignant solid tumors. The study protocol received approval from the institutional review board and ethics committee of Beidaihe Hospital, adhering to ethical guidelines. Written informed consent was obtained from all participants in accordance with the principles of the Declaration of Helsinki. Approximately 100 patients will be enrolled in multiple tumor-specific cohorts which will be independently statistically analyzed. ZSNeo-DC will be manufactured by Good Manufacturing Practice (GMP). Participants will receive seven subcutaneous injections of personalized DCs administered on Days 1, 8, 15, 22, 36, 50, and 64, either as monotherapy or in combination with immune checkpoint inhibitors according to routine clinical practice. Tumor response, progression-free survival, overall survival, safety, and antigen-specific immune responses will be evaluated throughout the study.

Вмешательства

• Биопрепарат Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）
  Personalized neoantigen-pulsed autologous dendritic cell Injections （ZSNeo-DC）will be manufactured by Good Manufacturing Practice (GMP). Mature dendritic cells are administered by subcutaneous injection to induce tumor-specific immune responses.
• Препарат Immune Checkpoint Inhibitors
  Approved immune checkpoint inhibitors may be administered according to the approved prescribing information and institutional clinical practice.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From first study treatment until 12 months after treatment initiation]

Вторичные конечные точки (7)

• Overall Survival [Срок оценки: From first treatment until death from any cause, assessed up to 24 months.]
• Disease Control Rate [Срок оценки: Up to 12 months.]
• Best Overall Response [Срок оценки: Up to 12 months.]
• Clinical Benefit Rate [Срок оценки: Up to 12 months.]
• Incidence of Adverse Events [Срок оценки: From informed consent until 30 days after the last administration of study treatment.]
• Progression-Free Survival [Срок оценки: From first study treatment until disease progression or death, assessed up to 24 months]
• Number of Participants With Serious Adverse Events [Срок оценки: From informed consent through 30 days after the last administration of personalized dendritic cell injection.]

Критерии участия

Критерии включения

• Participants must meet all of the following criteria:

• Male or female participants aged 18 to 75 years, inclusive.
• Histologically or cytologically confirmed malignant solid tumor.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate hematologic function, including:
• Adequate hepatic function:
• Adequate renal function:
• Adequate coagulation function:
• Adequate pancreatic function:
• Availability of sufficient tumor tissue and peripheral blood samples for whole-exome sequencing (WES), RNA sequencing (RNA-seq), and neoantigen identification.
• Adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection by leukapheresis.
• Left ventricular ejection fraction (LVEF) ≥50%.
• Estimated life expectancy of at least 3 months.
• Women of childbearing potential must have a negative pregnancy test within 7 days before the first administration of study treatment.
• Male participants and women of childbearing potential must agree to use highly effective contraception during treatment and for 3 months after the final administration.
• Ability to understand and voluntarily sign written informed consent.
• Willingness and ability to comply with study procedures and scheduled follow-up assessments.

Критерии исключения

• Participants meeting any of the following criteria will be excluded:

• T-cell-derived malignant tumors.
• Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
• Active autoimmune disease requiring systemic treatment.
• Active uncontrolled bacterial, viral, fungal, or opportunistic infection.
• Known human immunodeficiency virus (HIV) infection.
• Active hepatitis B or hepatitis C infection that is not adequately controlled.
• Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, severe arrhythmia, or congestive heart failure.
• Severe pulmonary, hepatic, renal, neurologic, psychiatric, or other uncontrolled systemic diseases judged by the investigator to interfere with study participation.
• Pregnant or breastfeeding women.
• Receipt of systemic immunosuppressive therapy within 14 days before leukapheresis, except physiologic corticosteroid replacement.
• Receipt of blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days before PBMC collection.
• Inability to undergo leukapheresis.
• Any condition that, in the investigator's opinion, would place the participant at unacceptable risk or compromise study integrity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beidaihe Hospital of Qinhuangdao — Qinhuangdao

Идентификаторы

NCT: NCT07752953 · ZSKY2026-B01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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