Galapagos Halts BCMA CAR-T Study Due to Parkinsonism Case

Study Suspension::
Galapagos has temporarily suspended enrollment in its Phase 1/2 PAPILIO-1 study evaluating GLPG5301, a BCMA-targeted CAR-T cell therapy, due to a case of Parkinsonism in a patient.

Parkinsonism Incidence::
The patient developed movement symptoms associated with Parkinson's disease, prompting the halt as a precautionary measure.

Regulatory Actions::
Galapagos has filed a protocol amendment with the European Medicines Agency (EMA) and anticipates resuming recruitment soon.

CAR-T Therapy Context::
Cases of Parkinsonism have also been reported with other CAR-T cell therapies, such as Janssen’s ciltacabtagene autoleucel (Carvykti) and Bristol-Myers Squibb’s idecabtagene vicleucel (Abecma).

Study Details::
The PAPILIO-1 study aims to evaluate the safety and efficacy of GLPG5301 in patients with relapsed/refractory multiple myeloma (rrMM) who have received at least two prior lines of therapy.

Positive Data from Other Trials::
Despite the pause, Galapagos reported positive data from its CD19-targeted CAR-T candidate GLPG5101 in patients with non-Hodgkin lymphoma, showing a high overall response rate and complete response rate.