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

Inclusion criteria

• 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.

Exclusion criteria

• 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.