NEW YORK – Synthekine on Thursday said it has treated the first blood cancer patient in a Phase I clinical trial of its autologous CAR T-cell therapy SYNCAR-001 plus its orthogonal interleukin-2 therapy STK-009.
The Phase I trial will include 36 patients with relapsed or refractory B-cell lymphomas, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia, among other hematologic malignancies. To be eligible for the trial, patients either need to have documented CD19-expressing lymphomas or a likelihood of CD19 expression based on histology.
As a primary endpoint, Synthekine is evaluating safety and toxicity, and secondary endpoints include objective response rates, duration of response, and progression-free survival, among other outcome measures.
The treatment regimen Synthekine is studying in the trial involves SYNCAR-001, a CD19-targeting CAR T-cell therapy engineered to express an IL-2 receptor. This receptor allows the CAR T cells to receive a signal from the STK-009 engineered IL-2 cytokine. According to Synthekine, the combined treatment regimen can overcome several of the limitations to established CD19-directed CAR T-cell therapies, including issues with expansion and persistence. In preclinical studies, STK-009 led to an expansion and activation of SYNCAR-001 cells, resulting in complete responses in preclinical lymphoma models.
"We believe that controllable, selective, and sustained cytokine support is central to the advancement of this class of treatment," Synthekine Chief Medical Officer Naiyer Rizvi said in a statement. "STK-009 plus SYNCAR-001 has the potential to drive deeper and more durable responses while avoiding serious toxicities related to uncontrollable CAR T-cell expansion for patients in need of better treatment options."