Senti Bio Announces First Patient Dosed in Phase 1 Clinical Trial of SENTI-202
- For the treatment of relapsed or refractory hematologic malignancies including acute myeloid leukemia (AML).
- SENTI-202 is a potential first-in-class Logic Gated off-the-shelf CAR-NK cell therapy.
- Initial clinical efficacy data expected by year-end 2024; durability data expected in 2025.
SOUTH SAN FRANCISCO, Calif. — May 13, 2024. Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that patient dosing has commenced in the Phase 1 clinical trial of SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia ("AML").
SENTI-202, a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer ("CAR-NK") investigational cell therapy, is designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies — including AML — while sparing healthy bone marrow cells.
About the Phase 1 trial
The Phase 1 clinical trial of SENTI-202 (NCT06325748) is enrolling adult patients with relapsed or refractory ("r/r") CD33 and/or FLT3 expressing hematologic malignancies, including AML, at multiple sites in the United States and Australia.
The dose finding trial is evaluating two dose levels — either 1 or 1.5 billion SENTI-202 cells — administered in cycles. Each cycle consists of three once-per-week doses, after disease-specific lymphodepleting conditioning. Patients may continue to receive multiple cycles of treatment based on safety and efficacy data.
GeneFab's role
Through Senti Bio's previously announced agreement with GeneFab, manufacturing of SENTI-202 — including the cell expansion and process work supporting clinical supply — is led by GeneFab's cGMP team in Alameda, CA. The agreement prepays the majority of manufacturing-related expenses through completion of the Phase 1 trial.
About AML
Acute myeloid leukemia is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. It is estimated there will be 20,800 new cases of AML in the United States in 2024, and the five-year survival rate for these patients is approximately 30%. AML is currently treated with chemotherapy, targeted therapies, and/or allogeneic or autologous stem cell transplant. For patients with relapsed or refractory AML, there are few treatment options and median overall survival is typically less than seven months.
About Senti Bio
Senti Biosciences is a biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging a synthetic biology platform called Gene Circuits to create therapies with enhanced precision and control.