First patient dosed in Phase 1 trial testing AML T-cell treatment
Safety study of CER-1236 recruiting blood cancer patients in 2 US states
The first participant in a U.S. Phase 1 clinical trial testing T-cell therapy candidate CER-1236 — Cero Therapeutics’ treatment for people with acute myeloid leukemia (AML), a form of blood cancer — has been dosed, according to the company.
“The completion of first-in-human dosing represents a clinical development milestone for CER-1236,” Robert Sikorski, MD, PhD, chief medical officer of Cero, said in a company press release.
About 18 adults with AML will take part in the Phase 1 trial (NCT06834282), which is still recruiting in Colorado and Texas.
Sikorski presented a poster outlining the study, titled “First in human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-L in acute myeloid leukemia (CertainT-1),” at the American Society of Clinical Oncology (ASCO) annual meeting, being held May 30 to June 3 in Chicago.
Researchers on lookout for possible side effects from CER-1236
AML is the most common type of leukemia in adults. It begins in the bone marrow, the spongy interior of some bones where blood cells grow and develop. Genetic mutations can cause immature blood cells to grow out of control. This growth takes up excessive bone marrow space and, ultimately, enters the bloodstream.
CER-1236 is an autologous T-cell therapy, meaning it uses a modified version of the patient’s own immune T-cells, designed to recognize leukemia cells.
An engineered receptor component allows CER-1236 to bind to T-cell membrane protein 4 (TIM-4) on the surface of cancerous cells. Once they bind, the T-cells can destroy the cancer cells and help alert the rest of the immune system, triggering a broader, long-term immune response against the tumor.
Cero’s T-cell therapy is designed to allow the T cells to engulf and break down tumor cells, similar to how certain immune cells naturally clean up harmful substances. Cero calls these modified cells Chimeric Engulfment Receptor T cells, or CER-T. The company believes CER-T cells could work better than other CAR-T therapies and might be used to treat both blood cancers and solid tumors.
Preclinical testing indicated early promise using TIM-4 as a binding target.
Now, in its first clinical trial, the company is testing the therapy in humans to assess potential safety concerns. These include side effects severe enough to require stopping or lowering the dose, as well as cytokine release syndrome, a potentially dangerous immune reaction that can cause symptoms like fever, low blood pressure, and difficulty breathing.
The researchers are also watching for signs of immune effector cell-associated neurotoxicity syndrome, a condition that affects the brain and may lead to confusion, seizures, or difficulty speaking.
Phase 1 will establish recommended dose for AML treatment
Individuals with AML who have experienced relapses, failure to respond to other treatments, continued disease activity through remission, or certain mutations may be eligible to participate in the study.
Along with CER-1236, participants will receive chemotherapy to lower some immune cells and help improve treatment efficacy. They will also be given mesna, a medicine that helps protect the body from harmful side effects caused by the chemotherapy.
The study is split into two parts. In the first part, Cero will test different doses of CER-1236, given as a single infusion. Based on safety results, the researchers will establish a recommended dosage to test in more participants during the second part.
“We look forward to communicating results as data matures,” Sikorski said.
Cero estimates the Phase 1 trial will run through the end of 2026. The first study participant received an infusion last month and is undergoing monitoring.
“We are grateful for the participation of our first patient and to the many people who have worked tirelessly to reach this milestone, including our CERO team, our consultants, and study sites,” said Chris Ehrlich, Cero CEO. “We look forward to discussing additional outcomes, which we continue to believe will validate the scientific work performed to date with CER-1236.”
About the Author
