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SENTI-202 · 1 trial · 3 indications
Incidence, type, frequency, and severity of adverse events and dose limiting toxicities will be assessed to determine the maximum tolerated dose and/or recommended phase 2 dose and dosing regimen
The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective disease
| Arm | Type | Description |
|---|---|---|
| SENTI-202 CAR NK cell therapy | EXPERIMENTAL | Part 1 Dose Finding: Sequential cohorts will receive doses of SENTI-202 using a modified 3+3 study design to determine the recommended phase 2 dose (RP2D). The starting dose will be 1 billion cells. Other doses may be explored depending on study data. Part 2 Cohort Expansion: After determination of the RP2D, additional subjects will be enrolled in disease-specific expansion cohorts at that dose to further explore safety, biodynamics, and anti-cancer activity of SENTI-202 |
| Name | Type | Description |
|---|---|---|
| SENTI-202 | BIOLOGICAL | SENTI-202 is an investigational off-the-shelf CAR NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematological malignancies while sparing healthy cells using a NOT logic gate. SENTI-202 is administered in either a 3 dose regimen (Schedule 1: Days 0, 7, 14) or a 5 dose regimen (Schedule 2: Days 0, 3, 7, 10, 14) of a 28-day treatment cycle following a lymphodepletion conditioning regimen of fludarabine and cytarabine (flu/Ara-C). Subjects will receive a minimum of 1 and maximum of 3 treatment cycles to achieve optimal response with the optionality of an additional consolidation cycle thereafter. Additional dosing schedules may be explored depending on study data. |
Inclusion Criteria: * Subjects with CD33 and/or FLT3 expressing malignancies, including: * Relapsed refractory acute myeloid leukemia (AML) with morphologic relapse as defined by ≥5% bone marrow blasts who have received at least 1 prior line, but no more than 3 prior lines of standard anti-AML t...
SENTI-202 is an investigational off-the-shelf logic gated CAR NK cell therapy being studied in adults with CD33 and/or FLT3 blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is in Phase 1 clinical development for these hematological malignancies.
SENTI-202 targets CD33 and FLT3, which are antigens expressed on certain hematological malignancies. The therapy is designed as a logic gated CAR NK cell therapy, meaning it is engineered to recognize these targets on cancer cells.
Senti Biosciences Holdings, Inc. (NASDAQ: SNTI) is developing SENTI-202. The company is conducting a Phase 1 clinical trial of this investigational cell therapy for blood cancers including AML and MDS.
SENTI-202 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The drug has received Orphan Drug designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
SENTI-202 is being studied in a Phase 1 clinical trial with the identifier NCT06325748. This trial is active but not recruiting, with an estimated enrollment of 21 participants. The study is taking place in the United States and Australia.
Yes, SENTI-202 is an off-the-shelf logic gated CAR NK cell therapy. It is being investigated for the treatment of CD33 and/or FLT3 expressing hematological malignancies, including AML and MDS, in adult patients.