Treatment for immune-related side effects that don't respond to standard therapy
Treatment of Immune-related Adverse Events Refractory to Standard Therapy and Associated Changes in Immunophenotype
This study is testing whether a new treatment called extracorporeal photopheresis or other immunosuppressive therapies can help patients with immune-related side effects that don't get better with standard steroid treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Munich) |
| Trial ID | NCT05700565 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients experiencing immune-related adverse events (irAEs) that are resistant to standard corticosteroid treatments or cannot be tapered off corticosteroids. Participants will receive either extracorporeal photopheresis (ECP) or alternative immunosuppressive therapies based on the investigator's choice. The study will monitor patients over a 24-week period, assessing symptoms, medication changes, and conducting laboratory investigations to evaluate safety and immunophenotype changes. Blood samples will be collected at multiple time points to analyze various biological markers and quality of life will be measured using a self-administered questionnaire.
Who should consider this trial
Good fit: Ideal candidates are patients who have developed irAEs after immune checkpoint inhibitor therapy and are either steroid-refractory or unable to taper corticosteroids effectively.
Not a fit: Patients with contraindications to ECP treatment or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients suffering from severe immune-related adverse events.
How similar studies have performed: While there have been studies on treating irAEs, the specific approach of using ECP for steroid-refractory cases is less common and may represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Munich
- LMU Klinikum Hauttumorzentrum — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Lucie Heinzerling — Department of Dermatology and Allergy, University Hospital, LMU Munich
- Study coordinator: Lucie Heinzerling
- Email: lucie.heinzerling@med.uni-muenchen.de
- Phone: +49 89 4400 56326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.