Master Protocol to Assess the Safety and Antitumor Activity of GeneticallyEngineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors(IGNYTE-ESO)
Trial ID: NCT03967223
Phase: Phase 2
Status: Active but not recruiting
Last Update Posted: April 2026
Please Note: This trial is no longer enrolling new patients but remains active for long-term follow-up of enrolled participants.
Eligibility: Individuals aged 10 and older with unresectable or metastatic synovial sarcoma or myxoid/round cell liposarcoma expressing the NY-ESO-1 antigen who are positive for HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 and have measurable disease. Substudy 1 accepts previously untreated patients; Substudy 2 requires prior anthracycline-based chemotherapy.
Overview: This Phase 2 master protocol evaluates letetresgene autoleucel (lete-cel), a NY-ESO-1-specific TCR-engineered T-cell therapy, across two substudies in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. Patients first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by a single infusion of their modified T-cells. Substudy 1 evaluates lete-cel as a first-line treatment, while Substudy 2 evaluates it as second-line or later therapy. The trial enrolled 103 patients across 38 sites in 8 countries.
Preliminary Effectiveness: As of the latest interim analysis, lete-cel demonstrated an overall response rate of 42% among 64 evaluable patients, including 6 complete responses and 21 partial responses. The median duration of response was 12.2 months and median progression-free survival was 5.3 months, indicating meaningful anti-tumor activity in heavily pre-treated patients.
Treatment Centers: USA, Canada, France, Italy, Netherlands, Spain, UK