RECRUITING

SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS

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Conditions

AML/MDSCD33 Expressing Hematological MalignanciesFLT3 Expressing Hematological MalignanciesSENTI-202CAR NKnatural killer cellCD33FLT3allogeneiclogic gaterelapsed/refractory AMLrelapsed/refractory MDSinhibitory CARactivating CARNOT logic gateIL15interleukin 15cell therapyoff-the-shelfleukemic stem cellsblastic plasmacytoid dendritic cell neoplasm (BPDCN)multiple myeloma (MM)mixed phenotype acute leukemia (MPAL)endomucin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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 Hematological Malignancies

Quick Facts

Study Start:2024-04-22
Study Completion:2040-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06325748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with CD33 and/or FLT3 expressing malignancies, including:
  2. * 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.
  3. * 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
  4. * Other hematological malignancies who have received at least 1 prior line of standard of care for the respective disease
  5. * Documentation of CD33 expression (or FLT3 expression if available) by individual institutional standard of care
  6. * ECOG performance score of 0-1
  7. * Adequate organ function including platelet count \>20x109/L (platelet transfusion is permitted)
  8. * Adequate recovery from toxicities from previous cancer treatments, as described in the study protocol
  9. * Willing and able to provide written informed consent
  1. * White blood cell (WBC) count of ≥20×109/L or circulating blasts ≥10×109/L or rapidly progressive/hyperproliferative disease
  2. * Acute promyelocytic leukemia with t(15;17) (q22;q12) or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA)
  3. * MDS with fibrosis (MDS-f) or known prior history of constitutional conditions/syndromes with chemo-responsive AML
  4. * Evidence of leukemic meningitis or known active central nervous system disease
  5. * Presence of extra-medullary disease or myeloid sarcoma alone with no morphologic hematologic relapse
  6. * 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
  7. * Hematopoietic cell transplantation (HCT) less than 100 days prior to the first dose of SENTI-202
  8. * Prior NK cell or CAR T cell therapy at any time
  9. * Prior donor lymphocyte infusion (DLI), except if after HCT for MRD+ disease
  10. * Medical conditions or medications prohibited by the study protocol
  11. * Pregnant or breastfeeding female

Contacts and Locations

Study Contact

Amy Alford, MA
CONTACT
650-239-2030
clinicaltrials@sentibio.com
Rochelle Emery, MD
CONTACT
650-239-2030
clinicaltrials@sentibio.com

Principal Investigator

Rochelle Emery, MD
STUDY_DIRECTOR
Senti Biosciences, Medical Director

Study Locations (Sites)

UCLA Medical Center
Los Angeles, California, 90095
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Methodist Healthcare
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Senti Biosciences

  • Rochelle Emery, MD, STUDY_DIRECTOR, Senti Biosciences, Medical Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-22
Study Completion Date2040-08

Study Record Updates

Study Start Date2024-04-22
Study Completion Date2040-08

Terms related to this study

Keywords Provided by Researchers

  • SENTI-202
  • CAR NK
  • natural killer cell
  • CD33
  • FLT3
  • allogeneic
  • logic gate
  • relapsed/refractory AML
  • relapsed/refractory MDS
  • inhibitory CAR
  • activating CAR
  • NOT logic gate
  • IL15
  • interleukin 15
  • cell therapy
  • off-the-shelf
  • leukemic stem cells
  • blastic plasmacytoid dendritic cell neoplasm (BPDCN)
  • multiple myeloma (MM)
  • mixed phenotype acute leukemia (MPAL)
  • endomucin

Additional Relevant MeSH Terms

  • AML/MDS
  • CD33 Expressing Hematological Malignancies
  • FLT3 Expressing Hematological Malignancies