Leads Biolabs reported on October 25, 2026, that patients in a dose-range group of its first-in-human LBL-034 trial had a median progression-free survival of 21.8 months. The experimental treatment is being studied in people with relapsed or refractory multiple myeloma.

Key Takeaways

  • The result covered 41 patients, and progression-free survival data were still immature at the July 16 cutoff.
  • Nearly all cytokine release syndrome events were low-grade; two patients experienced neurotoxicity and recovered.
  • Leads Biolabs said preparation for a Phase III trial is underway.

LBL-034 trial results and patient group

The company presented the updated data at the 2026 European Society for Medical Oncology annual meeting. Across the study, 56 patients had enrolled by July 16, 2026. They had received a median of 4.5 prior lines of therapy, ranging from three to 12.

The 21.8-month median progression-free survival result came from 41 patients treated at doses of 400 to 1,200 micrograms per kilogram, with a median follow-up of 17.8 months. Progression-free survival measures the time patients live without their disease worsening. The median duration of response had not been reached.

In reported subgroups, the overall response rate was 75.0% among patients with extramedullary disease and 85.7% among those whose prior BCMA-targeted therapy had failed.

Safety findings and development plans

Leads Biolabs said no dose-limiting toxicities were observed during dose escalation up to 1,200 micrograms per kilogram, and the maximum tolerated dose was not reached. One cytokine release syndrome event was grade 3 or higher. Two cases of immune effector cell-associated neurotoxicity syndrome were reported, and both patients recovered fully.

LBL-034 is a bispecific T-cell engager designed to target GPRC5D on tumor cells and activate T-cells. The company said preparation for a Phase III clinical trial is underway; it did not give a start date.

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