NEW YORK – The US Food and Drug Administration has granted Synthekine permission to begin testing a combination therapy with an autologous CAR T-cell therapy component as a treatment for patients with two forms of lupus and without the use of lymphodepletion, the company said Tuesday.
The FDA cleared an investigational new drug application for the company to evaluate SYNCAR-001 + STK-009 in patients with non-renal systemic lupus erythematosus (SLE) and lupus nephritis (LN). The combination therapy comprises SYNCAR-001, an autologous CD19-targeting CAR T that expresses an engineered IL-2 receptor, which is expressed on the surface of many lymphocytes. That IL-2 receptor selectively receives a signal from STK-009, an engineered pegylated IL-2 cytokine.
"By leveraging Synthekine’s orthoIL-2 technology, STK-009 has the potential to drive SYNCAR-001 cell engraftment and controlled cell expansion without lymphodepletion," a conditioning step in CAR T-cell therapies, Synthekine Chief Medical Officer Naiyer Rizvi said in a statement.
Synthekine expects to enroll the first patient into the multicenter, dose-escalation trial of the combination therapy in the second half of the year, evaluating the safety and clinical activity of it in patients with SLE and LN. Patients will receive a single dose of SYNCAR-001 cells and a limited course of STK-009 through weekly subcutaneous injections.
The Menlo Park, California-based firm is also testing SYNCAR-001 + STK-009 in a Phase I trial in CD19-positive hematologic malignancies.