SENTI-202 Shows Positive Preliminary Data in Acute Myeloid Leukemia

A phase 1 trial evaluating SENTI-202 demonstrated positive preliminary results in treating relapsed/refractory acute myeloid leukemia.

Positive preliminary data from a phase 1 clinical trial was recently announced evaluating SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (AML), according to a news release from Senti Biosciences.

SENTI-202 a first-in-class, off-the-shelf investigational cell therapy that uses engineered natural killer cells to target CD33 or FLT3 but not EMCN (CAR-NK), helping it more precisely attack certain blood cancers.

Data was presented on April 27 during a Clinical Trials Oral Minisymposium at the American Association for Cancer Research (AACR) Annual Meeting 2025.

“Senti was founded on engineering Logic Gated cell therapies with the enhanced ability to selectively kill cancer cells and protect healthy cells for cancer indications not addressable by existing drugs,” Dr. Timothy Lu, co-founder and CEO of Senti Biosciences, said in the news release. “Building upon these exciting results, we are continuing to prioritize development of our Logic Gating programs, including SENTI-202 and additional discovery efforts for solid tumors.”

Trial Efficacy and Safety

Two of three patients in the preliminary recommended phase 2 dose (RP2D) cohort achieved a composite complete remission. Among seven patients evaluable for best overall response, five achieved an overall response, including four who reached composite complete remission — three with full hematologic recovery and one with partial hematologic recovery.

All four patients who achieved composite complete remission were measurable residual disease negative by local standard of care. All patients who achieved composite complete remission remain in remission, with the longest follow-up exceeding eight months, and three patients went on to receive a bone marrow transplant after treatment with SENTI-202.

“While preliminary, the results demonstrated by SENTI-202 to date continue to be encouraging,” said Dr. Stephen A. Strickland, Jr., director, Leukemia Research for Sarah Cannon Research Institute, and the lead author for the AACR abstract, in the news release.

He continued, “There remains a significant unmet medical need in AML for treatments that can overcome tumor heterogeneity and spare healthy cells. Early results are encouraging, not only for the deep durable complete remissions, but also for the excellent safety profile noted thus far. I look forward to seeing additional data and exploring the potential of SENTI-202 to provide a much-needed treatment option to people living with AML.”

Regarding safety, SENTI-202 was generally well tolerated, with side effects consistent with other investigational natural killer cell therapies and patients with AML receiving lymphodepleting chemotherapy. Among grade 3 (severe) or higher side effects seen in more than one patient, four patients each experienced febrile neutropenia and low platelet count, and two patients each had anemia and abdominal pain. All but one of these effects were considered unrelated to SENTI-202 or attributed to lymphodepleting chemotherapy. No grade 5 (death) side effects occurred.

Continuation of Trial and Presentation of Data

The phase 1 study of SENTI-202 is continuing to enroll patients to confirm the preliminary recommended phase 2 dose, followed by disease-specific expansion cohorts.

“Based on our clinical, correlative and preclinical data, we believe SENTI-202 has the potential to provide a safe and effective treatment option for AML,” Dr. Kanya Rajangam, president, head of R&D and chief medical officer of Senti Bio, said in the news release. “We remain focused on the successful execution of the study and look forward to further exploring SENTI-202’s potential.”

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