Phase 1 Study of CD19 t-haNK Treatment for Patients Age 12 and Older With Relapsed B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying the safety and effectiveness of CD19 t-haNK, an investigational drug, in patients aged 12 years and older with relapsed B-cell acute lymphoblastic leukemia B-ALL. This phase 1, open-label trial aims to evaluate how patients respond to this treatment and monitor any side effects. The study focuses on patients who have relapsed after remission or have measurable residual disease following prior treatment cycles. Participants will receive CD19 t-haNK through intravenous infusions. Initially, three patients will receive doses spaced one week apart to assess safety. Treatment involves two 4-week cycles of the drug as a single agent, followed by a one-week safety pause, then an additional cycle with twice-weekly doses on an outpatient basis. Patients without disease progression may receive up to two more cycles. Bone marrow samples will be collected to monitor disease status, and treatment will stop if the disease worsens or if unacceptable side effects occur. During the trial, patients will undergo bone marrow aspirates for analysis around day 22 and every eight weeks thereafter. If no abnormal cells are found, further testing for minimal residual disease will be done. Safety assessments will be performed throughout, including monitoring for adverse reactions up to 12 months after the last dose. The study involves regular visits and follow-ups to evaluate both safety and preliminary effectiveness of the treatment over time.

A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia