Off-the-shelf CAR NK cell therapy for blood cancers
SENTI-202-101: A Phase 1, Multicenter, Open-Label Study of SENTI-202, a Selective Off-the-Shelf Logic Gated CAR NK Cell Therapy, in Subjects With CD33 and/or FLT3 Expressing Malignancies
This study is testing a new type of cell therapy called SENTI-202 to see if it can safely help adults with certain blood cancers like acute myeloid leukemia and myelodysplastic syndrome.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Senti Biosciences Industry-sponsored |
| Drugs / interventions | CAR T, chemotherapy |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Trial ID | NCT06325748 on ClinicalTrials.gov |
What this trial studies
This open-label phase 1 study evaluates the safety and anti-cancer activity of SENTI-202, a logic gated CAR NK cell therapy, in adults with CD33 and/or FLT3 expressing blood cancers, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The study employs a dose-finding approach using a modified '3+3' design to establish the maximum tolerated dose (MTD) and recommended phase two dose (RP2D) of SENTI-202 after lymphodepleting chemotherapy. Following this, disease-specific expansion cohorts will be treated at the RP2D to further assess efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults with relapsed refractory AML or MDS who have received prior lines of therapy and have documented CD33 or FLT3 expression.
Not a fit: Patients with early-stage blood cancers or those who have not received prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients with difficult-to-treat blood cancers.
How similar studies have performed: Other studies utilizing CAR NK cell therapies have shown promising results, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 therapy. Subjects with FLT3-mutated or IDH ½-mutated disease must have received at least one prior targeted therapy. * Relapsed refractory myelodysplastic syndrome (MDS) with increased blasts who have received at least 1 prior line, but no more than 2 prior lines of anti-MDS therapy * Other hematological malignancies who have received at least 1 prior line of standard of care for the respective disease * Documentation of CD33 expression (or FLT3 expression if available) by individual institutional standard of care * ECOG performance score of 0-1 * Adequate organ function including platelet count \>20x109/L (platelet transfusion is permitted) * Adequate recovery from toxicities from previous cancer treatments, as described in the study protocol * Willing and able to provide written informed consent Exclusion Criteria: * White blood cell (WBC) count of ≥20×109/L or circulating blasts ≥10×109/L or rapidly progressive/hyperproliferative disease * Acute promyelocytic leukemia with t(15;17) (q22;q12) or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA) * MDS with fibrosis (MDS-f) or known prior history of constitutional conditions/syndromes with chemo-responsive AML * Evidence of leukemic meningitis or known active central nervous system disease * Presence of extra-medullary disease or myeloid sarcoma alone with no morphologic hematologic relapse * Prior use of certain anti-cancer therapies and/or use within a certain number of days prior to SENTI-202 study treatment, as described in the study protocol * Hematopoietic cell transplantation (HCT) less than 100 days prior to the first dose of SENTI-202 * Prior NK cell or CAR T cell therapy at any time * Prior donor lymphocyte infusion (DLI), except if after HCT for MRD+ disease * Medical conditions or medications prohibited by the study protocol * Pregnant or breastfeeding female
Where this trial is running
Los Angeles, California and 7 other locations
- UCLA Medical Center — Los Angeles, California, United States (Recruiting)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Not_yet_recruiting)
- TriStar Bone Marrow Transplant — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Methodist Healthcare — San Antonio, Texas, United States (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Not_yet_recruiting)
- Peter MacCallum Cancer Center — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Amy Alford, MA
- Email: clinicaltrials@sentibio.com
- Phone: 650-239-2030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.