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

This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children. To be treated in this trial children must have a leukemia which did not respond or recurred after prior treatment. Luveltamab tazevibulin is an antibody-drug conjugate, which brings tazevibulin, an anticancer drug, to a molecule called FOLR1, present on the surface of CBFA2T3::GLIS2 AML cells.

Inclusion Criteria: * AML with CBFA2T3::GLIS2 gene fusion centrally confirmed * Refractory or relapsed disease with ≥ 5% bone marrow involvement with leukemic blasts 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 diseases associated 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 tubulin inhibitor * History of allogeneic hematopoietic stem cell transplant or any organ transplant in the prior 84 days * Graft versus host disease (GVHD) of any grade or GVHD treatment with exception of low dose steroids