NCT03412786

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

Completed Phase 1 Last updated 11 January 2022

What this trial tests

Phase 1 trial testing Bcl-Xl_42-CAF09b vaccine in Prostate Cancer in 20 participants. Completed in 8 December 2021.

Timeline

1 May 2018

Primary endpoint
8 December 2021

8 December 2021

Quick facts

Lead sponsor	Herlev Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 May 2018
Primary completion	8 December 2021
Estimated completion	8 December 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Bcl-Xl_42-CAF09b vaccine — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Herlev Hospital

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: Peptide-based vaccines in anticancer therapy.
   Bezu L, Kepp O, Cerrato G, Pol J, et al · · 2018 · cited 114× · PMID 30524907 · DOI 10.1080/2162402x.2018.1511506
2. Beyond Just Peptide Antigens: The Complex World of Peptide-Based Cancer Vaccines.
   Stephens AJ, Burgess-Brown NA, Jiang S. · · 2021 · cited 112× · PMID 34276688 · DOI 10.3389/fimmu.2021.696791
3. Development of Peptide-Based Vaccines for Cancer.
   Abd-Aziz N, Poh CL. · · 2022 · cited 100× · PMID 35342400 · DOI 10.1155/2022/9749363
4. Inhibition of Anti-Apoptotic Bcl-2 Proteins in Preclinical and Clinical Studies: Current Overview in Cancer.
   D'Aguanno S, Del Bufalo D. · · 2020 · cited 98× · PMID 32455818 · DOI 10.3390/cells9051287
5. Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma.
   Mørk SK, Kadivar M, Bol KF, Draghi A, et al · · 2022 · cited 47× · PMID 35036074 · DOI 10.1080/2162402x.2021.2023255
6. Recent Advances in Cancer Vaccines: Challenges, Achievements, and Futuristic Prospects.
   Gupta M, Wahi A, Sharma P, Nagpal R, et al · · 2022 · cited 41× · PMID 36560420 · DOI 10.3390/vaccines10122011
7. Vaccine approaches for antigen capture by liposomes.
   Zhou S, Luo Y, Lovell JF. · · 2023 · cited 27× · PMID 37878481 · DOI 10.1080/14760584.2023.2274479
8. Tumour-associated macrophages: versatile players in the tumour microenvironment.
   Ji ZZ, Chan MK, Chan AS, Leung KT, et al · · 2023 · cited 18× · PMID 37965573 · DOI 10.3389/fcell.2023.1261749