Belgium-based biotech Galapagos will resume enrollment in the phase 1/2 PAPILIO-1 study of its BCMA CAR-T candidate in relapsed/refractory multiple myeloma (rrMM), following a pause back in August.
Galapagos shared the news about the CAR-T candidate, GLPG5301, within the company’s third quarter financial results. GLPG5301 is an autologous, second-generation/4-1BB B-cell maturation antigen (BCMA)-directed CAR-T product candidate, administered as an intravenous infusion of a fresh product in a single fixed dose, at point-of-care.
PAPILIO-1 is a phase 1/2, open-label, multi-center study to evaluate the feasibility, safety, and efficacy of GLPG5301, in patients with rrMM after ≥2 prior lines therapy. Galapagos had paused enrollment back in August following one observed case of Parkinsonism.
These Parkinson’s-like cases — which can consist of slowing of movements, limb rigidity, micrographia, tremor, and other typical parkinsonian symptoms weeks to months after CAR T-cell infusion — are not exclusive to Galapagos. It’s a known adverse event observed in BCMA-direct CAR-T products, such as J&J and Legend Biotech’s approved CAR-T therapy, Carvykti.
Restarting the trial enrollment is good news for Galapagos who reported less than ideal financials earlier this year, including discontinuing its lupus CAR-T program and reducing its workforce.
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