ST-001 Shows Early Promise for Relapsed CTCL in Phase 1 Trial

ST-001 SST-001 nanoFenretinide showed promising early results in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL), including mycosis fungoides and Sézary syndrome, who had limited treatment options. In the Phase 1a trial, 25 heavily pretreated patients received the drug as a daily intravenous infusion for five days every three weeks.

The overall response rate was 28%, including one complete response and five partial responses. At the highest dose levels, the response rate increased to 42%. Most responses were seen within the first three weeks, and several patients maintained their response through the maximum eight treatment cycles.

The treatment was generally well tolerated, with no treatment-related deaths or major blood, heart, or nerve toxicities. Temporary high cholesterol and mild, reversible eye-related side effects were the main dose-limiting toxicities. Researchers are now planning a weekly dosing study and a Phase 1b trial to further evaluate ST-001.hows Early Promise for Relapsed CTCL in Phase 1 Trial