Allogene Therapeutics announces FDA clearance of ALLO-501 IND
Allogene Therapeutics in collaboration with its development partner Servier announced that the FDA has cleared Allogene's investigational new drug, or IND, application for ALLO-501 in patients with relapsed/refractory non-Hodgkin lymphoma, or NHL. Allogene is the sponsor of the ALLO-501 program. The Phase 1 portion of the study is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 in the most common NHL subtypes of relapsed/refractory diffuse large B-cell lymphoma or follicular lymphoma. ALLO-501 will be administered following lymphodepletion with fludarabine/cyclophosphamide and ALLO-647, Allogene's proprietary anti-CD52 monoclonal antibody. The ALPHA Phase 1 trial will treat up to 24 patients and is on track for initiation in the first half of 2019.