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Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

NCT05806814 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-03-05

No results posted yet for this study

Summary

Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

Conditions

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

BIOLOGICAL

Sipuleucel-T

Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.

Sponsors & Collaborators

  • Dendreon

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Kelly Stratton, MD · Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-12
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT05806814 on ClinicalTrials.gov