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

Recruiting now

Conditions studied: Immune-related Adverse Event

In brief

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.

Key facts

Study ID

NCT05700565

Run by

Lucie Heinzerling

People needed

50

Starts

2022-01-01

Expected to finish

2027-01-01

Last updated by the study team

2024-03-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must we willing and able to comply with scheduled visits and must have given written informed consent.
• irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade)
• irAE refractory to therapy with corticosteroids or inability to taper corticosteroids to prednisone equivalent <= 5mg. An irAE is defined as refractory if corticosteroids do not improve symptoms within 72 hours. The inability to taper corticosteroids is defined as relapse on standard tapering of 1 mg/kg corticosteroid over 28 days.

You may not qualify if…

• Contraindications for the treatment with ECP including a known sensitivity to psoralen compounds such as 8-MOP, comorbidities that may result in photosensitivity, aphakia, history of heparin-induced thrombocytopenia, unsatisfactory cardio-circulatory function, low hematocrit values
• Pregnancy
• Body weight less than 40 kg.

Where it is running

• LMU Klinikum Hauttumorzentrum — Munich, Germany (enrolling)

Full record on ClinicalTrials.gov

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