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

Launched by SUTRO BIOPHARMA, INC. · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called luveltamab tazevibulin for infants and children under 12 years old who have a rare form of acute myeloid leukemia (AML) caused by a genetic change known as CBFA2T3::GLIS2. This trial is for children whose leukemia did not respond to previous treatments or has come back after being treated. The goal is to see if this new treatment is safe and effective for these young patients.

To participate in the trial, children must have this specific type of leukemia confirmed by tests and show a certain level of disease involvement in their bone marrow. Participants should be younger than 12 years and have enough health and organ function to take part. The trial is currently recruiting, and children who join can expect to receive the study drug while being closely monitored by doctors. It's important for families to know that this trial excludes children with certain other health issues or recent treatments that could interfere with the study.

Gender

ALL

Eligibility criteria

• 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