MedTrace Logo

Safety Study of BPX-201 Dendritic Cell Vaccine Plus AP1903 in Metastatic Castrate Resistent Prostate Cancer

NCT01823978 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-10-08

No results posted yet for this study

Summary

This is a Phase I, non-randomized, dose escalation study of the safety, biomarkers, and preliminary efficacy of dendritic cell vaccine, BPX-201, plus activating agent, AP1903, in patients with metastatic castrate resistant prostate cancer.

Conditions

  • Castrate Resistent Prostate Cancer

Interventions

BIOLOGICAL

BPX-201 vaccine plus AP1903

The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively. Dose escalation will occur according to a 3+3 design. Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks). Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit. On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.

Sponsors & Collaborators

  • Bellicum Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lawrence Fong, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-05-31
Completion
2017-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01823978 on ClinicalTrials.gov