eligibility_summary
Eligibility: Children <12 with relapsed/refractory AML with CBFA2T3::GLIS2 fusion and ≥5% marrow blasts, Lansky ≥50, adequate organ function. Exclude: active CNS3, significant corneal disorders or conditions increasing AML toxicity, active/uncontrolled infection or severe illness, prior FOLR1-targeting or tubulin-inhibitor ADCs, transplant within 84 days, any GVHD or treatment except low-dose steroids.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Luveltamab tazevibulin (STRO-002, Luvelta), an antibody-drug conjugate (IgG1 SP8166) targeting folate receptor-α (FOLR1). Mechanism: Binds FOLR1 on leukemic blasts, internalizes, and via a cathepsin-cleavable linker releases a 3-aminophenyl hemiasterlin payload (SC209) that inhibits tubulin polymerization, inducing mitotic arrest and cell death. Study: Phase 1/2 in infants/children <12 with relapsed/refractory CBFA2T3::GLIS2 AML, IV dosing 3.5 or 4.3 mg/kg every 2 weeks. Cells/pathways targeted: FOLR1-expressing CBFA2T3::GLIS2 AML cells (RAM phenotype: CD56+, low CD45/CD38/HLA-DR), microtubules and G2/M cell-cycle checkpoint.