USFDAMay 14, 2026, 08:41 AM
Senti Bio SENTI-202 to registrational trial; Donor X shows 50% cCR rate
AI Summary
Senti Biosciences announced the successful completion of a Type B RMAT meeting with the FDA for SENTI-202, its CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia (R/R AML). Following the meeting, the company plans to proceed with a single-arm, multi-center pivotal trial for potential registration. Exploratory analysis of Phase 1 data identified a "Donor X" attribute correlating with improved efficacy, showing a 50% composite complete remission (cCR) rate in patients receiving Donor X-derived cells, leading to a decision to use only Donor X material for future manufacturing. The therapy continues to show durable MRD-negative responses.
Key Highlights
- Senti Bio completed a Type B RMAT meeting with the FDA for SENTI-202.
- Company plans a single-arm, multi-center pivotal trial for SENTI-202 in R/R AML.
- Phase 1 data showed 50% composite CR (cCR) rate (7/14 patients) with Donor X-derived NK cells.
- Non-Donor X NK cells resulted in a 12.5% cCR rate (1/8 patients).
- All future SENTI-202 manufacturing will utilize Donor X material.
- Overall response rate (ORR) was 44% and cCR was 37.5% at RP2D across all patients.
- Complete remissions are durable, with the longest duration exceeding 21 months.
- SENTI-202 holds RMAT and Orphan Drug Designation from the FDA.