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

NCT05700565 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Immune-related Adverse Event

Interventions

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

Sponsors & Collaborators

  • Lucie Heinzerling

    lead OTHER

Principal Investigators

  • Lucie Heinzerling · Department of Dermatology and Allergy, University Hospital, LMU Munich

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Germany

Study Locations

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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 NCT05700565 on ClinicalTrials.gov