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

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.

Timeline

Start

2018-05-01

Primary completion

2021-12-08

Completion

2021-12-08

Publications

• Mork SK, Kongsted P, Westergaard MCW, Albieri B, Granhoj JS, Donia M, Martinenaite E, Holmstrom MO, Madsen K, Kverneland AH, Kjeldsen JW, Holmstroem RB, Lorentzen CL, Norgaard N, Andreasen LV, Wood GK, Christensen D, Klausen MS, Hadrup SR, Thor Straten P, Andersen MH, Svane IM. First in man study: Bcl-Xl_42-CAF(R)09b vaccines in patients with locally advanced prostate cancer. Front Immunol. 2023 Mar 14;14:1122977. doi: 10.3389/fimmu.2023.1122977. eCollection 2023.

Drugs

Indications