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NOT YET RECRUITING
NCT07905027
PHASE1

A Study of CLEC2A CAR T for Pediatric and Adult Patients With Relapsed or Refractory AML

Sponsor: Seattle Children's Hospital

View on ClinicalTrials.gov

Summary

This is a phase I, open-label, non-randomized clinical trial that will enroll pediatric and adult research participants with CLEC2A+ acute myeloid leukemia (AML) that does not go away with treatment (is refractory) or comes back after treatment (is recurrent). The goal is to evaluate the safety, feasibility, and efficacy of administering T cell products (modified immune cells) derived from the research participant's blood that have been genetically modified to express chimeric antigen receptor (CAR) targeting SC-CAR.CLEC2Av1. The main questions it seeks to answer are: * How safe is the T cell product infusion (modified immune cells)? * How feasible is it to manufacture the cell products? Participants will first receive treatments to prepare their body (bridging therapy and lymphodepletion). On Day 0, they receive a single infusion of CLEC2A CAR T cells, which are modified immune cells designed to target and fight cancer. Researchers will evaluate the safety and side effects of the treatment, check how well the CAR T cells survive and multiply in the body over time (using blood, bone marrow, and cerebrospinal fluid samples), and assess how well the treatment fights the AML. Bone marrow tests are performed on Day 28 to check the response.

Official title: ADVANCE-01: A Phase 1 Study of CLEC2A CAR T for Pediatric and Adult Patients With Relapsed or Refractory AML

Key Details

Gender

All

Age Range

Any - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-11

Completion Date

2043-02

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Biological SC-CAR.CLEC2Av1

Subjects will receive a single dose of CLEC2A CAR T cells. CD4+ and CD8+ T cell subsets will be isolated from an apheresis product obtained from the research participant. The isolated cells will be stimulated with a anti-CD3/28 activation reagent beads and transduced with a self-inactivating (SIN) lentiviral vector that directs the expression of the CLEC2A CAR.

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States