Study Summary
This is an open label, single-centre phase 1/2 study involving a single dose of Temferon, an investigational Advanced Therapy Medicinal Product (ATMP), to treat patients with metastatic clear cell renal cell carcinoma (RCC) with evidence of disease progression following at least two lines of standard of care (SoC) treatments.
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TemferonGENETIC
Autologous CD34+-enriched hematopoietic progenitor cells exposed in vitro to specific lentiviral vector encoding for the human interferon-alpha 2 gene. Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of interferon-alpha2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny.
PembrolizumabBIOLOGICAL
Pembrolizumab 400mg IV every 6 weeks commencing at D+30
CabozantinibDRUG
40mg QD once PD occurs as assessed at D+30 or at subsequent visits
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Ospedale San Raffaele | Milan | Italy | Italy |