Seattle cancer center opens as new trial site for experimental cell therapy
Fred Hutch begins enrolling patients with myelofibrosis, other blood cancers
Written by |
A clinical trial testing CER-1236, an experimental cell therapy for advanced myelofibrosis and other blood cancers, has expanded enrollment to the Fred Hutch Cancer Center in Seattle. (Photo from iStock)
A new site in Seattle has begun enrolling patients in an early-stage clinical trial testing CER-1236, an experimental cell therapy for difficult-to-treat blood cancers, including myelofibrosis.
The activation of the Fred Hutch Cancer Center expands recruitment for the Phase 1/1b CERTAIN-T study (NCT06834282), bringing the total number of participating U.S. clinical sites to five. Jacob Appelbaum, MD, PhD, an assistant professor at the University of Washington School of Medicine and physician at Fred Hutch, serves as principal investigator at the Seattle center.
“We are gratified to be working with these important institutions and welcome the team at Fred Hutch to our clinical trial team,” Chris Ehrlich, CEO of treatment developer Cero Therapeutics, said in a company press release. “We look forward to continuing to provide updates as the trial progresses.”
Addressing bone marrow scarring in myelofibrosis
Myelofibrosis is a rare, chronic blood cancer marked by abnormal blood cell production and persistent inflammation that leads to severe scarring in the bone marrow, the spongy tissue inside bones where blood cells form. Over time, this scarring prevents the body from producing enough healthy blood cells, resulting in symptoms such as fatigue, weakness, an enlarged spleen, and anemia, a shortage of oxygen-carrying red blood cells.
Although JAK inhibitor therapies, such as Jakafi (ruxolitinib), can help manage symptoms, some people eventually stop responding to these treatments or experience disease progression, highlighting the need for additional therapeutic options.
CER-1236 is an investigational cell therapy that uses a person’s own T-cells, a type of immune cell that can kill other cells. The cells are collected and modified in the lab to carry a chimeric engulfment receptor (CER), a lab-made cell surface protein designed to enable T-cells to physically engulf and destroy cancer cells. Cero calls these engineered cells CER-T cells.
When the CERTAIN-T study launched last year, investigators initially limited enrollment to adults ages 18 to 85 with acute myeloid leukemia (AML), a fast-growing cancer of the blood and bone marrow.
The trial’s protocol was expanded earlier this year to include people with myelofibrosis who were previously treated with a JAK inhibitor, and those with myelodysplastic syndrome, another form of blood cancer that can impair healthy blood cell production.
The trial’s primary objectives are to evaluate the safety and tolerability of CER-1236. Secondary goals include tracking how the engineered cells survive and distribute throughout the body, as well as early indicators of anti-cancer activity.
Early safety and response data in leukemia patients
Cero has previously reported findings from six AML patients in the first two dose groups. Patients in the first group received 1 million CER-T cells per kilogram of body weight, while those in the second group received 4 million cells/kg, administered in two infusions.
All three participants in the second dose group completed a 28-day safety evaluation period without experiencing dose-limiting toxicities, mirroring results seen in the first three participants.
The company also reported no treatment-related severe adverse events, as well as no cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, two serious complications that can occur with some cell therapies.
Early signs of clinical improvement occurred in two AML patients, though formal response assessments are still ongoing.
One patient whose disease had resisted multiple prior therapies responded well enough to proceed to a potentially curative stem cell transplant more than two months after receiving CER-1236. Clinical teams continue to track the post-transplant recovery and long-term outcomes.
Cero emphasized that these observations remain early and do not establish CER-1236’s effectiveness. Clinical outcomes specific to patients with myelofibrosis have not yet been reported.
Leave a comment
Fill in the required fields to post. Your email address will not be published.