NCT05700565 Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
| NCT ID | NCT05700565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lucie Heinzerling |
| Condition | Immune-related Adverse Event |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must we willing and able to comply with scheduled visits and must have given written informed consent. 2. irAE after immune checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA4 blockade) 3. 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. Exclusion Criteria: 1. 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 2. Pregnancy 3. Body weight less than 40 kg.
Contact & Investigator
Lucie Heinzerling
PRINCIPAL INVESTIGATOR
Department of Dermatology and Allergy, University Hospital, LMU Munich
Frequently Asked Questions
Who can join the NCT05700565 clinical trial?
This trial is open to participants of all sexes, studying Immune-related Adverse Event. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05700565 currently recruiting?
Yes, NCT05700565 is actively recruiting participants. Contact the research team at lucie.heinzerling@med.uni-muenchen.de for enrollment information.
Where is the NCT05700565 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT05700565 clinical trial?
NCT05700565 is sponsored by Lucie Heinzerling. The principal investigator is Lucie Heinzerling at Department of Dermatology and Allergy, University Hospital, LMU Munich. The trial plans to enroll 50 participants.