Senti Biosciences has completed enrolment of patients in its Phase I clinical trial assessing SENTI-202 in adults with relapsed or refractory acute myeloid leukaemia (r/r AML).
The company is developing SENTI-202 as a cluster of differentiation 33/fms-like tyrosine kinase 3 (CD33/FLT3)-targeting Logic Gated chimeric antigen receptor natural killer (CAR NK) cell therapy.
Senti Biosciences recently presented data at the American Society of Hematology (ASH) Annual Meeting, showing that SENTI-202 led to deep, MRD-negative, durable complete remissions and a favourable safety profile in heavily pretreated r/r AML patients.
Following completion of enrolment, Senti Biosciences plans to engage with the US Food and Drug Administration (FDA) in the first half of 2026 about progressing to a pivotal registration programme, including potential studies in newly diagnosed and paediatric AML.
SENTI-202 has obtained regenerative medicine advanced therapy (RMAT) designation, which may expedite its development and review process.
The product incorporates an OR GATE to kill target cells, a NOT GATE to spare healthy cells, and calibrated-release IL-15 to enhance cell persistence.
The FDA has granted orphan drug designation (ODD) and RMAT status to SENTI-202 for treating relapsed or refractory haematologic malignancies, including AML.
Senti Biosciences chief medical officer Kanya Rajangam said: “The completion of enrolment in our Phase I trial represents a significant clinical milestone for our SENTI-202 programme.
“Importantly, the encouraging clinical data from this study provide a strong foundation as we actively design our pivotal programme for SENTI-202 in AML, as well as potential indication expansion and later-stage clinical development.
“We look forward to having productive discussions and working closely with the FDA in the first half of this year to discuss the next phase of development for our RMAT-designated programme.”
In January 2024, Senti Biosciences cut 37% of its workforce as it reallocated funds to advance the clinical development of SENTI-202.
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