SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
Condition(s) studied
Investigational drug(s) / intervention(s)
SENTI-202: 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.
Study summary
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.
Eligibility
Primary outcome measure(s)
- Safety and tolerability for dose determination of SENTI-202 — At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years
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 - For subjects enrolled in the Dose Expansion Cohort(s): Anti-cancer activity of SENTI-202 — Through study completion, up to 2 years
The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective disease
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Mayo Clinic | Jacksonville | Florida | |
| TriStar Bone Marrow Transplant | Nashville | Tennessee | |
| MD Anderson Cancer Center | Houston | Texas | |
| Methodist Healthcare | San Antonio | Texas | |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | |
| Peter MacCallum Cancer Center | Melbourne | Victoria |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06325748 on ClinicalTrials.gov ↗ ← All trials in Australia