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Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
Trial Status: administratively complete
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06679582.
Locations matching your search criteria
United States
California
Los Angeles
Children's Hospital Los Angeles
Status: Approved
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Name Not Available
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Name Not Available
Tennessee
Memphis
Saint Jude Children's Research Hospital
Status: Approved
Name Not Available
This is a registrational international, multicenter, two-part open label Phase 1/2 trial
in an extremely rare pediatric disease (around 17 new patients a year in US and 10 in
EU). Part 1 randomizes subjects 1:1 to one of two luveltamab tazevibulin dose cohorts (1a
and 1b). Part 2 further evaluates the safety and the efficacy of the selected dose.
Subjects who achieve complete remission after two cycles of treatment may continue
luveltamab tazevibulin as monotherapy, while non-responders at PI discretion may add
luveltamab tazevibulin with standard of care (SOC) AML treatments. Luveltamab tazevibulin
is given IV every two week as monotherapy and every 4 weeks when given with chemotherapy.
