NCT05700565

Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Lucie Heinzerling · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This study is an open, monocentric study. It includes patients with irAE refractory to standard therapy or patients where corticosteroids cannot be tapered. Patients will either be treated with ECP or second line immunosuppressive therapy according to investigator's choice. Patients will be followed for 24 weeks after first treatment.

Detailed description

At inclusion patient history including type of tumor and immunotherapy will be obtained. At all visits symptoms, changes in concomitant medication, a medical assessment and laboratory investigations will be performed. Blood sampling for safety analysis and for investigating the immunophenotype will be performed at baseline, week 1, 4, 8 and 12. Laboratory values assessed include: * Complete blood count * Chemistry including liver enzymes (AST, ALT) and total bilirubin in the case of immune-related hepatitis, CK in case of myositis, creatinine in case of nephritis * Inflammatory markers: CRP, IL-6, Procalcitonin Peripheral blood mononuclear cells (PBMC) will be used to determine immunophenotype, including the amount of NK-cells, regulatory T- cells and myeloid-derived suppressor cells (MDSC) as well as the expression of inflammatory markers. Biological samples will be frozen for later analysis. Additionally, patients will assess their symptoms and their quality of life by a self-administered questionnaire at baseline and week 4, 8 and 12. Quality of life will be assessed by EORTC QLQ-C30. All irAE will be graded according to CTCAE.

Conditions

• Immune-related Adverse Event

Interventions

Type	Name	Description
OTHER	Extracorporeal photopheresis	ECP consists of the three steps of leukapheresis, photoactivation and reinfusion and has immunomodulatory effects (modulation of dendritic cells, change in cytokine profile, induction of T cell subpopulations). Indications are currently the treatment of Sézary syndrome, Graft-versus-host disease (GvHD), organ transplant rejection and systemic scleroderma.
OTHER	Other immunosuppressive or immunomodulatory drugs	Other immunosuppressive or immunomodulatory drugs

Timeline

• Start date: 2022-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-01-26
• Last updated: 2024-03-15

Locations

1 site across 1 country: Germany