Iovance registers two new trials: IOV-5001 solid tumor study and lifileucel sarcoma trial

Two new Iovance-sponsored trials were registered on ClinicalTrials.gov this week, both listed as not yet recruiting.

• IOV-5001, an experimental TIL therapy, is entering a Phase 1/2 first-in-human study. The trial is a Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes regimen with IOV-5001 in participants with previously treated advanced solid tumors.¹ IOV-5001 is genetically modified to express inducible membrane-tethered interleukin-12, which the company says may enhance antitumor activity compared with non-genome-edited TIL products.¹ The study plans to enroll Phase 2 cohorts in non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and head and neck squamous cell carcinoma¹, with an estimated enrollment of 106 participants¹ and an estimated start of 2026-09¹.
• Lifileucel, a TIL therapy also known as LN-145, is set for a new Phase 2 trial in soft tissue sarcoma called "SARATOGA," a Phase 2, multicenter, open-label study of lifileucel in participants with previously treated advanced soft tissue sarcoma.² The trial will enroll patients with histologically confirmed unresectable or metastatic undifferentiated pleomorphic sarcoma (Cohort 1) or dedifferentiated liposarcoma (Cohort 2), who have received at least 1 and a maximum of 3 prior systemic therapies, including at least 1 anthracycline-based regimen.² Estimated enrollment is 80 participants², with a planned start of 2026-09-01².