Study on Luveltamab Tazevibulin for Infants and Children Under 12 with Difficult-to-Treat AML

Sponsor: Sutro Biopharma, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06679582

Provider View

This clinical trial is testing a new treatment, luveltamab tazevibulin, for infants and children under 12 with a rare type of acute myeloid leukemia (AML) that has not responded to previous treatments or has returned. The study aims to see if this treatment is safe and effective.

Patient Parameters

Program Overview

The trial is focused on a rare form of acute myeloid leukemia (AML) in infants and children, which has a specific genetic abnormality called CBFA2T3::GLIS2. The study will test if luveltamab tazevibulin, a drug that targets cancer cells, is safe and can help treat this type of leukemia. Children eligible for the trial must have leukemia that did not respond to previous treatments or has come back after treatment. Luveltamab tazevibulin works by delivering a cancer-fighting drug directly to the leukemia cells.

Description

This international study is being conducted in multiple centers and is divided into two parts. It is designed for a very rare pediatric disease, with only about 17 new cases each year in the US and 10 in the EU. In the first part of the study, children are randomly assigned to receive one of two different doses of luveltamab tazevibulin. The second part of the study will further assess the safety and effectiveness of the chosen dose. If a child achieves complete remission after two cycles of treatment, they may continue receiving luveltamab tazevibulin alone. If the leukemia does not respond, the treatment may be combined with standard AML therapies, based on the doctor's decision. Luveltamab tazevibulin is given through an IV every two weeks when used alone and every four weeks when combined with chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with AML that has the CBFA2T3::GLIS2 gene fusion.
  • The leukemia has not responded to treatment or has returned, with at least 5% of bone marrow affected.
  • Under 12 years old.
  • Able to perform daily activities with a Lansky performance score of 50 or higher.
  • Have adequate organ function.

Exclusion Criteria

  • Active disease in the central nervous system (CNS).
  • Pre-existing significant eye disorders or conditions that increase the risk of treatment side effects.
  • Active or uncontrolled infections or other severe illnesses.
  • Previous treatment with drugs targeting FOLR1 or similar drugs containing a tubulin inhibitor.
  • History of stem cell or organ transplant within the last 84 days.
  • Any grade of graft versus host disease (GVHD) or treatment for GVHD, except for low-dose steroids.

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