Belgian biotech Galapagos has temporarily suspended enrollment in a Phase I/II trial of its CAR-T candidate GLPG5301 for relapsed or refractory multiple myeloma. The move, announced alongside the company's second-quarter earnings report, comes after a patient in the study developed Parkinsonism, and mirrors similar events observed with other therapies in the field.GLPG5301 is a personalised BCMA-directed CAR-T therapy given as a single, fixed-dose intravenous infusion directly at the point of care. The PAPILIO-1 study got underway in December. It aims to determine the recommended dose of GLPG5301 in Phase I and evaluate overall response rate in Phase II, while also assessing the feasibility of point-of-care manufacturing, with patients being monitored for 24 months.Jeevan Shetty, Galapagos' head of clinical development oncology, said the temporary hold was being done out of "an abundance of caution…[to] really interrogate this particular patient history" by reviewing all components of their characteristics, as well as seeking external guidance and advice. He noted that the case involved an "atypical patient presentation that is different from what is out there in the limited literature" on the subject."We have undertaken a number of steps, additional specific safety measures," Shetty said, adding that the company already submitted a protocol amendment to the European Medicines Agency in June, with plans to resume recruitment "imminently."The occurrence of Parkinsonism in BCMA CAR-T recipients has been reported before. Johnson & Johnson and Legend Biotech's Carvykti (ciltacabtagene autoleucel) includes Parkinsonism as a risk in its boxed warning. The label for Bristol Myers Squibb's Abecma (idecabtagene vicleucel), which is directed against BCMA as well, mentions a Grade 3 Parkinsonism adverse event as having occurred after treatment in a multiple myeloma study, though there is no specific warning.Despite the setback, Galapagos indicated that it remains committed to its CAR-T programme. The company continues to advance its CD19-directed CAR-T candidates, GLPG5101 and GLPG5201, for non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL), respectively.It submitted an IND application to FDA for the Phase I/II ATALANTA-1 study of GLPG5101 in relapsed/refractory NHL. In addition, a filing for a Phase II study of GLPG5201 in relapsed/refractory CLL has been submitted in the EU, while an IND for the Phase I/II EUPLAGIA-1 study in the same indication is planned for the fourth quarter.