NCT05546723

LMY-920 for Treatment of Relapsed or Refractory Myeloma

LUMT1A22, Phase 1 Study of BAFF CAR T Cells (LMY-920) for Treatment of Relapsed or Refractory Myeloma (LMY-920-002)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Luminary Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAFF ligand CAR-T cells in relapsed and refractory myeloma.

Detailed description

In this open label, dose escalation study, up to four dose levels of autologous BAFF ligand CAR-T cells (LMY-920) will be evaluated for treatment relapsed and refractory myeloma. BAFF receptor family includes B-cell activating factor receptor (BR3), B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design. The primary goal of this study is to determine recommended phase II dose of human LMY-920 in patients with relapsed or refractory myeloma.

Conditions

• Multiple Myeloma, Refractory
• Multiple Myeloma in Relapse

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CAR-T cell therapy expressing the BAFF-ligand.	LMY-920

Timeline

• Start date: 2024-03-13
• Primary completion: 2025-07-31
• Completion: 2025-10-31
• First posted: 2022-09-21
• Last updated: 2024-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study