Trial testing cell therapy for hard-to-treat AML now full in both countries
Developer planning talks with FDA on pivotal study of SENTI-202
Written by |
Enrollment is now complete for an early clinical study assessing the safety and tolerability of SENTI-202, Senti Biosciences’ cell therapy candidate for adults with hard-to-treat acute myeloid leukemia (AML), a type of blood cancer.
The Phase 1 trial (NCT06325748) enrolled an estimated 21 people, ages 18 to 74, at sites in the U.S. and Australia. Eligible participants had been diagnosed with relapsed/refractory AML or other forms of blood cancer and had previously received at least one prior line of treatment. Relapsed indicates the cancer returned after initially responding to treatment, while refractory means the cancer did not respond adequately to prior therapy or continued to progress despite treatment.
The study, now underway at five sites in the U.S. and three in Australia, is open-label, meaning both researchers and participants know the medication being given. The trial was launched in 2024.
According to a company press release, Senti is now gearing up for talks with the U.S. Food and Drug Administration (FDA) on plans for a pivotal trial that may support the treatment’s U.S. approval for relapsed or refractory AML. Those discussions, which will take place in the first half of this year, will also evaluate expanding the trial to newly diagnosed AML patients or to children with AML.
“Importantly, the encouraging clinical data from this study provide a strong foundation as we actively design our pivotal program for SENTI-202 in AML, as well as potential indication expansion and later-stage clinical development,” said Kanya Rajangam, MD, PhD, chief medical officer at Senti Bio. “We look forward to having productive discussions and working closely with the FDA … to discuss the next phase of development for our … [therapy] program.”
A type of blood cancer, AML occurs when immature white blood cells multiply rapidly, replacing healthy cells and causing anemia — low levels of red blood cells in the body — infections, and bleeding.
AML therapy uses natural killer cells to target cancer
SENTI-202 uses natural killer (NK) cells, a type of immune cell that can kill cancer cells, from a healthy donor. These cells are modified to express a chimeric antigen receptor (CAR) targeting CD33 or FLT3, which are found on some blood cancer cells, while preventing NK cells from attacking healthy cells.
Before the treatment, participants must undergo a lymphodepletion regimen, using two chemotherapy medications to eliminate the patient’s immune cells and make room for the modified cells.
Data from the Phase 1 trial have demonstrated that half of the evaluable patients with relapsed or refractory AML treated at the recommended Phase 2 dose achieved treatment response, while 42% reached complete remission or complete remission with partial hematologic recovery. Complete remission means that no detectable signs of leukemia were found in the bone marrow and blood following treatment, along with recovery of blood cell counts to normal levels. Complete remission with partial hematologic recovery means that leukemia cells were no longer detectable, but some blood cell counts had not yet fully returned to normal levels.
All patients with complete responses achieved deep minimal residual disease negativity, meaning no cancer cells were detected with highly sensitive methods.
The trial also demonstrated that SENTI-202 had a good safety profile and confirmed its mechanism of action by selectively killing AML cells while sparing healthy cells.
According to Rajangam, “the completion of enrollment in our Phase 1 trial represents a significant clinical milestone for our SENTI-202 program.”
SENTI-202 has been granted FDA orphan drug and regenerative medicine advanced therapy designations for the treatment of relapsed/refractory blood cancers, including AML. These designations aim to encourage the development of therapies to treat rare diseases and cellular therapies with the potential to address unmet needs in serious health conditions.
