CYTO-102 is being developed by City of Hope and CytoImmune.
The first patient has been dosed in the phase 1 clinical trial (NCT05334329) of City of Hope and CytoImmune’s natural killer (NK) cell therapy CYTO-102 for the potential treatment of relapsed/refractory non-small cell lung cancer (NSCLC).
“We are thrilled to initiate patient dosing with CYTO-102, in partnership with City of Hope, which marks our transition into a clinical-stage company and brings us an important step closer to understanding the potential our tumor-reactive NK cell-based therapies may have for treating patients with cancer,” Christina Coughlin, MD, PhD, chief executive officer, CytoImmune, said in a statement. “We’ve engineered CYTO-102 to be an off-the-shelf cell therapy that can directly kill cancer cells, broadly stimulate the body’s own endogenous immune system, and enhance tumor killing through generation of a highly effective immune response ultimately leading to improved patient outcomes. We look forward to advancing this trial in an effort to bring the next generation of cellular therapies to patients in need.”
CYTO-102 is a novel cellular therapy consisting of PD-L1-positive tumor-reactive TRACK-NKTM cells. The NK cells are genetically modified to secrete high levels of soluble IL-15 and are primed with other signals, including cytokines IL-12 and IL-18 along, during manufacturing to induce PD-L1 expression. TRACK-NKTM cells are PD-L1-positive and naturally directed to the tumor microenvironment to kill cancer cells and coordinate the patient’s adaptive or T cell response.
The dose-escalation trial is assessingthe safety and tolerability of CYTO-102 as a monotherapy and in combination with atezolizumab in around 21 patients with relapsed or difficult-to-treat NSCLC. The primary endpoints of the trial are safety, determining the optimal biological dose, and cellular kinetics and persistence of the NK cells. Secondary endpoints will assess response and survival rates, including complete and partial responses, disease control and stable disease rates, duration of response, progression free survival and overall survival rates at 6 months and 1 year after treatment. Other study objectives include phenotype and activation status, T-cell activation and cytokine analysis of the NK cells.
Patients will receive a fludarabine and cyclophosphamide regimen prior to CYTO-102 infusion. After infusion, patients will be followed for 30 days, every 8 weeks until disease progression, and then annually for 15 years.
“City of Hope is committed to making a difference in the lives of patients with cancer with a goal of transforming the future of cancer care,” Michael Caligiuri, MD, president and Deana and Steve Campbell Physician-in-Chief Distinguished Chair, City of Hope National Medical Center, and scientific founder, CytoImmune, added to the statement. “NSCLC continues to be a challenging cancer to treat and despite advancements, too many patients are left without durable and effective options. We are pleased to advance this novel cellular therapy together with CytoImmune, which could offer patients with NSCLC a promising new treatment option.”