NCT03381768

Peptide Vaccination Against PD-L1 and PD-L2 in Relapsed Follicular Lymphoma

PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Lars Møller Pedersen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients with relapsed follicular lymphoma.

Detailed description

Follicular lymphoma (FL) is the the most common of the indolent lymphomas, with an incidence in Denmark of 220 per year. In 90% of the cases the disease is incurable why the treatment strategy often is watchful waiting until significant signs of progression or transformation. After chemotherapy, maintenance therapy is often used to increase disease control. The microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. One escape mechanism is the PD-L1 and PD-L2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the T-cells. By stimulating the T-cells to attack PD-L1 and PD-L2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control. 10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	PD-L2 peptide	100 ug PD-L2 peptide dissolved in DMSO and water mixed with 500ul montanide.
BIOLOGICAL	PD-L2 and PD-L1 peptide	100 ug PD-L2 peptide and 100ug PD-L1 peptide dissolved in DMSO and water mixed with 500ul montanide.

Timeline

• Start date: 2017-12-12
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2017-12-22
• Last updated: 2021-02-24

Locations

1 site across 1 country: Denmark