A company founded by former executives of Kite Pharma will start a Phase I study of a so-called “off-the-shelf” CAR-T therapy in the first half of this year, now that it has the Food and Drug Administration’s authorization to do so.

South San Francisco, California-based Allogene Therapeutics said Monday the FDA had cleared its Investigational New Drug application to start the 24-patient study, titled ALPHA, which it will run with French drugmaker Servier. The trial will enroll patients with relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma, who will receive the CAR-T, ALLO-501 and a CD52-targeting monoclonal antibody, ALLO-647.

ALLO-501 targets CD19, an antigen widely expressed in B-cell non-Hodgkin’s lymphomas like DLBCL and FL. The CAR-T will be administered following a lymphodepletion regimen of the chemotherapy drugs fludarabine and cyclophosphamide, which are meant to give the CAR-T cells room to expand. ALLO-647 is given as part of the lymphodepletion regimen. A commercially available CD52-targeting monoclonal antibody, Sanofi’s Campath (alemtuzumab), is used with other CAR-T therapies.

Allogene was founded last year by David Chang and Arie Belldegrun, co-founders of CAR-T manufacturer Kite Pharma, which Gilead Sciences acquired in 2017 for $11.9 billion. Kite was the developer of Yescarta (axicabtagene ciloleucel), an autologous CAR-T that won FDA approval for DLBCL in October 2017. Its main competitor is Novartis’s Kymriah (tisagenlecleucel), which is also approved for DLBCL, along with acute lymphoblastic leukemia in children and young adults.

In contrast with Yescarta and Kymriah, ALLO-501 is an allogeneic CAR-T, meaning it is made from donor T cells rather than the patient’s own cells. Allogene has another allogeneic CAR-T, UCART19, which like ALLO-501 was licensed from Cellectis.

Data presented at the American Society of Hematology’s 2018 annual meeting on UCART19 in 20 adults and children with ALL showed that 14 of the 16 who were evaluable for efficacy achieved a complete response with or without complete hematological recovery within 28 or 42 days of infusion. Twelve patients achieved minimal residual disease negativity, meaning no detectable cancer cells. OF the MRD-negative patients, five remained in remission between 4.5 and 16.4 months after receiving UCART19.

Photo: CGToolbox, Getty Images

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