In the safety analysis of these 7 patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment. Only 1 patient (DL1) progressed (progressive disease, (PD) after partial response (PR)) and had a CD19-negative relapse with confirmed RT. A duration of response of up to 7.9 months has been reported and follow-up is ongoing. 6 out of 7 patients (86%) reached a complete response (CR) and all Richter’s patients achieved a CR. Moreover, the initial efficacy results are encouraging with an objective response rate (ORR) of 100% observed. The initial results from these 7 patients that were eligible for efficacy analysis (cut-off date: 9 January 2023) indicated that a 7-day vein-to-vein time is feasible and demonstrated strong and consistent in vivo CAR-T expansion levels. The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (dose level 3 (D元)) CAR+ viable T cells. All patients received GLPG5201 as a fresh infusion with a median vein-to-vein time of 7 days. “Our innovative approach in CAR-T cell therapy development and manufacturing underscores our commitment to accelerating transformational innovation to address the unmet needs of patients with advanced cancers, and we very much look forward to meeting and connecting with you at our booth.”Īt the safety and efficacy analysis cut-off date of 9 January 2023, 7 patients diagnosed with rrCLL (including 4 patients with RT) were enrolled in the EUPLAGIA-1 study (n=4 at dose level 1 (DL1) n=3 at dose level 2 (DL2)). The previously disclosed initial efficacy, safety and feasibility data from the ongoing EUPLAGIA-1 study with our CD19 CAR-T candidate, GLPG5201, manufactured at point-of-care, are encouraging, and we are on track to provide Phase 1 topline results around mid this year,” said Jeevan Shetty, Head of Clinical Development Oncology at Galapagos. “Patients who develop rrCLL and become resistant to new agents have a very poor prognosis and a significant high unmet medical need for novel therapeutic options such as CAR-T cell therapy.
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