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Bcl-XL_42-CAF09b Vaccination for Patients With Prostate Cancer With Lymph Node Metastases

NCT03412786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-11

No results posted yet for this study

Summary

In this Phase I study, patients with hormone-sensitive Prostate Cancer (PC) and lymph node metastases are treated with the cancer vaccine Bcl-xl\_42-CAF09b. The aim of the study is to clarify the safety and toxicity of the vaccine and also the immunological effect.

The vaccine Bcl-xl\_42-CAF09b is composed of the peptide Bcl-xl\_42 and the adjuvant CAF09b. The B-cell lymphoma extra large protein (Bcl-xl) protein plays a vital role in the cancer cell's ability to avoid programmed cell death (apoptosis) and is upregulated in a variety of cancerous diseases. Bcl-xl\_42 is a peptide fragment of the full protein and preclinical studies have shown that vaccination with this peptide (Bcl-xl) can activate the immune system and thereby lead to the death of cancer cells. In order to improve the activation of the immune system, adjuvant CAF09b is added; Preclinical studies have shown that special intraperitoneal (IP) injections of CAF09b improve the activation of the immune system.

Conditions

Interventions

BIOLOGICAL

Bcl-Xl_42-CAF09b vaccine

The vaccine consists of 0.05 mg peptide (bcl-xl\_42) and 625 μg DDA, 125 μg MMG og 31 μg Poly I:C (CAF09b) mixed in a 0.5 ml emulsion

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Inge Marie svane · Sponsor GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT03412786 on ClinicalTrials.gov