NEW YORK – Galapagos on Thursday said it has been cleared by the US Food and Drug Administration to begin a Phase I/II trial of its autologous CD19 CAR T-cell therapy GLPG5101 in patients with relapsed or refractory non-Hodgkin lymphoma.
The trial, called ATALANTA-1, is currently ongoing in Europe, and early results from the study have shown response rates of 87.5 percent and 93.3 percent in the Phase I and Phase II portions, respectively.
The trial will evaluate the safety and preliminary efficacy of GLPG5101 and determine the recommended dose for Phase II with a primary endpoint of objective response rate. Secondary objectives of the trial include the feasibility of decentralized manufacturing of the therapy. Patients will be followed for two years after enrollment.
Galapagos, based in Belgium, is using its decentralized cell therapy manufacturing platform to manufacture GLPG5101. The firm's goal is to achieve a seven-day manufacturing turnaround time for its CAR T-cell therapies. Last year, Galapagos partnered with Landmark Bio in Boston to manufacture batches of its cell therapies for clinical trials.
The firm's clinical-stage CAR T-cell therapy pipeline includes another CD19-directed program for the treatment of relapsed or refractory chronic lymphocytic leukemia and Richter transformation, as well as a BCMA-directed therapy for relapsed or refractory multiple myeloma.