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SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
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.
Study details:
This is a dose-finding study of SENTI-202, comprised of an initial dose finding using a modified "3+3" study design to determine the maximum tolerated dose (MTD) and recommended phase two dose (RP2D) of SENTI-202 when administered after lymphodepleting chemotherapy (Part 1) followed by disease-specific expansion cohorts at the RP2D (Part 2).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-04-22
Primary completion: 2025-09-01
Study completion finish: 2040-08-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06325748
Intervention or treatment
BIOLOGICAL: SENTI-202
Conditions
- • AML/MDS
- • CD33 Expressing Hematological Malignancies
- • FLT3 Expressing Hematological Malignancies
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: SENTI-202 CAR NK cell therapy
| BIOLOGICAL: SENTI-202
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Safety and tolerability for dose determination of SENTI-202 | 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 | At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Anti-cancer activity of SENTI-202 | The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective disease | Through study completion, up to 2 years |
Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202 | Levels of circulating SENTI-202 and peripheral cytokine levels will be measured to assess the PK/PDn profile of SENTI-202 | Through study completion, up to 2 years |
Host immune response to SENTI-202 | Anti-SENTI-202 immune response and RCR will be measured in blood samples | Through study completion, up to 2 years |
Frequently Asked Questions
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