Treatment for infants and children with a rare type of leukemia
A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)
This study is testing a new drug for infants and children under 12 with a specific type of leukemia to see if it can help them get better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Day to 12 Years |
| Sex | All |
| Sponsor | Sutro Biopharma, Inc. Industry-sponsored |
| Drugs / interventions | luveltamab, chemotherapy |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06679582 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of luveltamab tazevibulin, an antibody-drug conjugate, in treating infants and children under 12 years old with relapsed or refractory acute myeloid leukemia (AML) that has the CBFA2T3::GLIS2 genetic fusion. The study is divided into two parts: the first part randomizes participants to different dosing cohorts, while the second part focuses on further assessing the selected dose's safety and efficacy. Participants who achieve complete remission may continue treatment, while non-responders may receive additional standard AML therapies. The drug is administered intravenously, with treatment schedules varying based on response.
Who should consider this trial
Good fit: Ideal candidates are infants and children under 12 years old with relapsed or refractory AML confirmed to have the CBFA2T3::GLIS2 gene fusion.
Not a fit: Patients with active central nervous system disease or those who have previously received certain targeted therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with a rare and difficult-to-treat form of leukemia.
How similar studies have performed: While this specific approach is novel for this rare pediatric AML, similar antibody-drug conjugates have shown promise in other cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 3 other locations
- Childrens Hospital of Alabama — Birmingham, Alabama, United States (Recruiting)
- Childrens National Hospital — Washington, District of Columbia, United States (Recruiting)
- Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States (Recruiting)
- VCU Massey Cancer Center-Adult Outpatient Pavillion — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Anna Butturini, MD
- Email: CBFGLISAML@sutrobio.com
- Phone: 650-881-6581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.