Phase III Study of ALETA-001 Given by Intravenous Infusion Every Two Weeks in Adults with B-cell Lymphoma Who Have Received Anti-CD19 CAR T-Cell Therapy

What this Trial Is About

Researchers are evaluating ALETA-001, a new chimeric antigen receptor CAR T-cell engager, in people with B-cell malignancies who have previously received anti-CD19 CAR T-cell therapy. This Phase III open-label trial aims to study the safety, tolerability, timing, pharmacokinetics, and effectiveness of ALETA-001. The study is divided into a safety lead-in phase to find the best dose and timing, followed by a dose expansion phase to further assess safety and therapeutic activity. In the trial, ALETA-001 will be given by intravenous infusion every two weeks. The Phase I safety lead-in will test different dose levels and timing to decide on a recommended dose for Phase II. Phase II will focus on monitoring safety, drug levels in the blood, and how well the treatment works. Participants will receive ALETA-001 as a single agent throughout the study. Participants will be closely monitored with radiological scans before starting treatment and for up to 12 months afterward to assess response. Safety data will be collected from consent until 95 days after the last dose, and survival will be followed for up to 48 months. Researchers will also measure drug concentration and clearance in the blood during the first week after infusion. The total participation time varies depending on individual treatment and follow-up schedules.

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies