Condition: Melanoma Stage III · Melanoma Stage IV · Melanoma · Sponsor: Inge Marie Svane
The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement. Participants will undergo: * screening * tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks * admission for lymphodepleting chemotherapy (Cyclophosphamide and Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses * Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET/CT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.
This description comes directly from the study's public registry record.
Inge Marie Svane, Prof., M.D · 38683868 · inge.marie.svane@regionh.dk
Cecilie Vestergaard, M.D · 38686589 · cecilie.dam.vestergaard@regionh.dk
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| Department of Oncology | Herlev, Denmark | Recruiting |
| Department of Oncology | Herlev, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06204991