A CLINICAL TRIAL 1

PHASE I/​IB STUDY OF NK EXPRESSING AN AFFINITY-ENHANCED T-CELL RECEPTOR (TCR) AGAINST THE NY-ESO-1

This is an open-label phase 1 study to determine how well NY-ESO-1 TCR/IL-15 NK is tolerated, its safety, and the dose range in patients with relapsed/refractory synovial sarcoma or myxoid/round cell liposarcoma, who have undergone at least one prior line of therapy involving doxorubicin and/or ifosfamide. NY-ESO-1 TCR/IL-15 NK is a cell therapy that uses natural killer cells from cord blood to mount an immune response in the body to treat sarcoma. Before receiving the NY-ESO-1 TCR/IL-15 NK dose, patients undergo a process to deplete existing T-cells, setting the stage for the new therapy.

Over the following 12 months, twelve scheduled visits to the study doctor will be required, with most appointments expected to occupy a whole day for standard sarcoma-related testing. Patient support services provided for travel for the appointments.

Clinicaltrials.gov: https://clinicaltrials.gov/study/NCT06083883?cond=synovial%20sarcoma&term=TCR-NK&rank=1

PHASE 1 TRIAL OF THE LSD1 INHIBITOR SECLIDEMSTAT (SP-2577) WITH AND WITHOUT TOPOTECAN AND CYCLOPHOSPHAMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY EWING SARCOMA AND SELECT SARCOMAS

This is an open label, phase I trial to evaluate the safety of an orally administered targeted agent, seclidemstat (LSD1 inhibitor) in combination with cyclophosphamide and topotecan, in patients with relapsed or refractory Ewing sarcoma who have received at least one line of prior treatment for Ewing sarcoma. The trial also enrolls both myxoid liposarcoma and Ewing-related sarcomas which share a similar translocation gene as Ewing sarcoma, who have received at least two prior lines of treatment for their sarcoma. The myxoid liposarcoma and translocated sarcoma patients will be enrolled to single-agent seclidemstat. This trial has completed the dose escalation phase of the trial and is now in dose expansion. The primary objective is safety and tolerability of seclidemstat, alone, and in combination with standard chemotherapy.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03600649?term=salarius&draw=2&rank=2
Sponsor Website: http://salariuspharma.com/