Early Phase 1 Study of 4A10 Antibody Infusion for Adults With Relapsed or Hard-to-Treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Focusing on Safety and Drug Behavior

What this Trial Is About

Researchers are evaluating a new antibody drug called 4A10 in adults with relapsed or hard-to-treat acute lymphoblastic leukemia ALL or lymphoblastic lymphoma. This early Phase 1 trial aims to test the safety, determine appropriate dosing, and study how the drug behaves in the body. 4A10 targets a protein called CD127 found on leukemia cells to block their growth and help the immune system attack them. Participants receive 4A10 through weekly intravenous infusions in 28-day treatment cycles. The study begins with small groups receiving increasing doses while closely monitoring for side effects during the first 4 to 6 weeks. Patients who tolerate and respond to treatment may continue for up to six cycles, or until disease progression or other reasons for stopping. Throughout the trial, participants are carefully observed for treatment side effects and how their bodies process the drug. Researchers will measure safety outcomes, determine the recommended dose for future studies, and look for early signs of anti-tumor activity. The study duration averages about one year, including monitoring for adverse events and drug effects.

First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.