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YS247 (Neoantigen-Pulsed DC Vaccine) for Metastatic Prostate Cancer

NCT07583160 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase I study tests a personalized cancer vaccine (Neo-DC) for men with advanced prostate cancer (metastatic castration-resistant prostate cancer, or mCRPC) that has continued to grow despite standard hormone therapies and other treatments.

The vaccine is custom-made for each participant using their own immune cells (dendritic cells) mixed with specific tumor markers (neoantigens) unique to their cancer. These neoantigens are identified through genetic sequencing of the patient's tumor. The goal is to help the body's immune system recognize and attack the cancer cells specifically.

The study will enroll approximately 9 to 18 men and will test three different dose levels to find the safest amount. Participants will receive the vaccine as an injection under the skin every two weeks for a total of 4 doses over an 8-week treatment period.

The main purpose is to evaluate the safety of this vaccine, determine the maximum tolerated dose, and identify any serious side effects. Researchers will also look at whether the vaccine helps lower PSA levels (a blood marker for prostate cancer), slows cancer growth, and stimulates an immune response against the tumor.

Participants will be monitored closely during treatment and followed for several months afterward to assess long-term safety and effects.

Conditions

  • Metastatic Castration-Resistant Prostate Cancer Patients
  • Castration-Resistant Prostate Cancer (CRPC)
  • Prostate Neoplasms

Interventions

BIOLOGICAL

Autologous Neoantigen-Pulsed Dendritic Cell Vaccine

Personalized autologous dendritic cell vaccine manufactured from patient-derived peripheral blood mononuclear cells (PBMCs). Dendritic cells are differentiated ex vivo using GM-CSF and IL-4, loaded with patient-specific synthetic neoantigen peptides (identified via NGS sequencing of tumor tissue), and matured using TNF-α, IFN-γ, and PGE2. The vaccine is administered subcutaneously at 1-3 sites (axillary or inguinal lymph node regions) every 2 weeks for a total of 4 doses. Each injection site receives 0.3 mL cell suspension. Three sequential dose cohorts: 5×10⁶ cells (low), 1×10⁷ cells (medium), and 1.5×10⁷ cells (high) per dose.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2029-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583160 on ClinicalTrials.gov