Novartis CAR-T Phase II JULIET study in DLBCL briefly hit with manufacturing hiccup in Europe; experts say unlikely a long-term problem
Novartis (VTX:NOVN) temporarily encountered manufacturing problems at its European chimeric antigen receptor T-cell (CAR-T) manufacturing facility, forcing at least one site in the Phase II JULIET trial of tisagenlecleucel-T in diffuse large B-cell lymphoma (DLBCL) to go through the US facility, a source with knowledge of the situation said. The logistical issue occurred after the European sites’ activation and resulted in lengthening the time between apheresis and reinfusion, the source added.
However, other experts said such issues would not likely create insurmountable logistical hurdles in the future.
While not providing details about the problems that occurred or when, the source said Novartis resolved the issue within a few weeks. Yet, the need to ship the product back and forth across national borders can create import-export hurdles that take time to overcome, which can be a problem for patients with an aggressive disease like DLBCL, the source said. Experts said there is confidence that such issues could be resolved and that international shipping of live cells is already a familiar practice in allogeneic stem cell transplantation (alloSCT), though the fragility of cell products means it is important to ensure smooth logistics.