Phase III Study of LBL-034 to Assess Safety and Effectiveness in Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are conducting a phase III clinical study to assess the safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness of LBL-034 in patients with relapsed or refractory multiple myeloma, including plasma cell leukemia. The study includes a dose-escalation phase to find the recommended dose and a dose-expansion phase to evaluate treatment effects. The trial is open-label and involves multiple centers. The treatment involves intravenous infusions of LBL-034 at an initial dose defined as the maximum tolerated dose MTD, given every two weeks. The study has two parts the phase I dose escalation and expansion to assess safety and dosage, followed by phase IIa which evaluates efficacy in four patient cohorts. Biological samples will be collected from all participants for testing. Participants will undergo various assessments including monitoring for objective response rate, dose-limiting toxicities, and maximum tolerated dose during treatment and up to 30 days after stopping the drug. Additional evaluations include drug concentration levels, immunogenicity, minimal residual disease, and duration of response. The total trial duration extends until May 2027, with patients followed closely throughout treatment and after drug withdrawal.

A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma