GLPG5301: BCMA CAR-T in relapsed and refractory multiple myeloma

GLPG5301 is a second-generation/4-1BB B-cell maturation antigen (BCMA)-directed CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5301 are being evaluated in the PAPILIO-1 Phase 1/2, open-label, multicenter study in patients with relapsed/refractory multiple myeloma (R/R MM) after ≥2 prior lines of therapy.

The primary objective of the Phase 1 part of the PAPILIO-1 study is to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The primary objective of the Phase 2 part of the study is to evaluate the efficacy of GLPG5301, as measured by the Objective Response Rate (ORR). Secondary objectives for both Phase 1 and Phase 2 include further assessment of the safety of GLPG5301, additional efficacy endpoints, including assessment of Minimal Residual Disease (MRD), as well as the feasibility of decentralized manufactured GLPG5301 in R/R MM patients. Each enrolled patient will be followed for 24 months. During Phase 1, up to 2 dose levels will be evaluated and at least 12 patients will be enrolled to establish the recommended Phase 2 dose. Approximately 30 additional patients will be enrolled in the Phase 2 part of the study to further evaluate the safety and efficacy of GLPG5301.

The Phase 1 part of the PAPILIO-1 Phase 1/2 study is currently recruiting patients. Upon completion of Phase 1 and analysis of the data, we will evaluate the most appropriate development strategy and next steps.

We aim to present Phase 1 data at a future medical conference.

PAPILIO-1 Phase 1/2 study design of GLPG5301 in R/R MM