Senti Biosciences has received an additional $1.0 million milestone payment from the California Institute of Regenerative Medicine (CIRM) following successful clinical enrollment achievements for its investigational CAR-NK cell therapy SENTI-202. The payment brings the company's total funding received under the $8 million CIRM grant to $7.4 million, supporting the ongoing Phase 1 clinical development of this potential first-in-class treatment for relapsed/refractory blood cancers.
Promising Early Clinical Results
SENTI-202 has demonstrated encouraging preliminary efficacy and safety data in its ongoing Phase 1 trial (NCT06325748). The therapy showed strong tolerability with no dose-limiting toxicities observed and no maximum tolerated dose reached. Based on the totality of clinical data, researchers identified a preliminary recommended Phase 2 dose of 1.5 x 10^9 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles following lymphodepleting chemotherapy.
The early efficacy results were particularly noteworthy. Among the 7 best overall response evaluable patients across all dose levels, 5 achieved an overall response rate (composite complete remission plus morphologic leukemia-free state), while 4 of the 7 achieved composite complete remission (cCR). This included 3 patients with complete remission with full hematologic recovery and 1 with complete remission with partial hematologic recovery.
In the preliminary recommended Phase 2 dose cohort specifically, 2 of 3 patients achieved composite complete remission. All 4 patients who achieved cCR were measurable residual disease negative as assessed by local standard of care, with the longest cCR duration extending beyond 8 months and ongoing.
Innovative Logic Gated Technology
SENTI-202 represents a novel approach to CAR-NK therapy through its Logic Gated design. The off-the-shelf therapy is engineered as a CD33 OR FLT3 NOT EMCN CAR NK cell product, designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells.
This precision targeting mechanism addresses a critical challenge in blood cancer treatment by potentially reducing damage to healthy tissue while maintaining therapeutic efficacy against malignant cells. The therapy utilizes Senti Bio's proprietary Gene Circuit platform to engineer enhanced precision and control into the treatment.
Clinical Development Progress
The positive preliminary results and correlative data from patients, along with preclinical data supporting the Logic Gate mechanism of action, were recently presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. These data support the continued advancement of SENTI-202 through clinical development.
"We are grateful for the continued support of the CIRM as we continue to rapidly enroll into our SENTI-202 clinical trial. We are committed to advancing this important program forward and based on the recently presented positive preliminary results, we are becoming more confident in its potential to provide a much-needed treatment option for patients," commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences.
The milestone-based funding structure from CIRM reflects the program's progress in meeting predetermined clinical development goals, particularly around patient enrollment targets. This funding model aligns financial support with tangible clinical advancement, providing validation of the program's execution and potential.
