Senti Biosciences Completes Phase 1 SENTI-202 Trial Enrollment, RMAT Designation Fuels Pivotal AML Push
Senti Biosciences has completed patient enrollment in its Phase 1 trial of SENTI-202, a first-in-class CD33/FLT3-targeted CAR NK cell therapy for relapsed or refractory AML. The trial’s ASH 2025 data showed deep MRD-negative remissions and favorable safety, and the company plans FDA discussions in H1 2026 for a pivotal program and expanded indications, leveraging RMAT designation.
1. Phase 1 Enrollment Completed
Senti Biosciences has finished enrolling adult patients in its Phase 1 study of SENTI-202, a logic-gated, off-the-shelf CAR NK cell therapy targeting CD33 and FLT3 in relapsed or refractory acute myeloid leukemia. Completion of enrollment marks a key clinical milestone ahead of pivotal program planning.
2. Positive Clinical Data Presented
At ASH 2025, SENTI-202 demonstrated deep, MRD-negative, durable complete remissions and a favorable safety profile in heavily pretreated AML patients. The data underpin confidence in the therapy’s potential to eradicate leukemic blasts and stem cells while sparing healthy marrow.
3. Regulatory and Development Plans
Senti Bio is preparing for FDA discussions in the first half of 2026 to design a pivotal, registration-enabling trial of SENTI-202 in relapsed/refractory AML and to explore expanded use in newly diagnosed and pediatric AML. The therapy’s RMAT designation may accelerate development and review timelines.