FDA Clears IND Application for UCART19 in Adult Leukemia Patients
The U.S. Food and Drug Administration (FDA) has granted Servier an Investigational New Drug (IND) clearance to proceed with the clinical development of UCART19 in adult patients with relapsed/refractory acute lymphoblastic leukemia.
Servier, along with partners Pfizer and Cellectis, has received clearance from the U.S. Food and Drug Administration (FDA) to advance the clinical development of UCART19 in the United States. UCART19 is an allogeneic, gene-edited cell therapy candidate intended for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
The IND clearance allows for the expansion of the CALM Phase 1 study to include multiple U.S. centers, including the MD Anderson Cancer Center. Servier is sponsoring the CALM study, which began in the UK in August 2016. The company acquired exclusive rights to UCART19 from Cellectis in 2015, with Pfizer collaborating on its development.
The CALM study is an open-label, dose-escalation trial designed to assess the safety, tolerability, and anti-leukemic activity of UCART19 in patients with CD19-positive B-cell ALL that has relapsed or become refractory to treatment. The FDA's review, which followed a meeting of the Recombinant DNA Advisory Committee (RAC), enables the U.S. expansion.
UCART19 is an allogeneic CAR T-cell product candidate for CD19-expressing hematologic malignancies. This therapy offers a potential "off-the-shelf" solution, aiming to overcome the logistical challenges associated with autologous CAR T-cell therapies that require individual patient-specific production. Pfizer holds exclusive rights within the U.S. for UCART19's development and commercialization, while Servier retains rights elsewhere.