Allogene Therapeutics, a clinical-stage biotech developing allogeneic CAR T therapies for cancer, known as AlloCAR T, in collaboration with its development partner Servier, said that the U.S. Food & Drug Administration (FDA) has cleared Allogene’s Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory non-Hodgkin lymphoma (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 (DLBCL) or follicular lymphoma (FL). ALLO-501 will be administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) 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.
 
“I am very pleased with the Allogene team’s ability to accelerate the ALLO-501 program by securing the FDA’s clearance of our IND,” said David Chang, president, chief executive officer, Allogene. “This significant milestone for the company, as well as the planned initiation of the ALPHA trial, brings us one step closer to making CAR T therapy ‘on demand’ and more broadly accessible to patients when they are at a critical stage in their disease.” 
 
Patrick Therasse, head of research and development, oncology, Servier, said, “We are delighted that this program will soon be moving into the clinic. The upcoming clinical study will enable the teams to investigate the potential benefits of allogeneic CAR T therapy in patients with non-Hodgkin lymphoma, one of the largest hematological indications.”
 
UCART19 and ALLO-501 are being developed under a joint clinical development collaboration between Servier and Allogene, and are exclusively licensed from Cellectis. UCART19 and ALLO-501 utilize the TALEN gene-editing technology pioneered and owned by Cellectis. Both ALLO-501 and UCART19 feature the same construct and editing but are manufactured using a different process. The UCART19 clinical program for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL) is sponsored by Servier. Allogene has exclusive rights to UCART19 and ALLO-501 in the U.S. while Servier retains exclusive rights for all other countries.