Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML

Inclusion Criteria:

• AML with CBFA2T3::GLIS2 gene fusion centrally confirmed

• Refractory or relapsed disease with ≥ 5% bone marrow involvement with leukemicblasts by morphology

• Age < 12 years.

• Lansky performance of ≥ 50

• Adequate organ functions

Exclusion Criteria:

• Active central nervous system (CNS) disease (CNS3)

• Pre-existing clinically significant corneal disorders or constitutional diseasesassociated with an increased risk of AML treatment toxicities

• Active or uncontrolled infections or other active severe intercurrent illnesses,

• Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulininhibitor

• History of allogeneic hematopoietic stem cell transplant or any organ transplant inthe prior 84 days

• Graft versus host disease (GVHD) of any grade or GVHD treatment with exception oflow dose steroids