FDA Grants Clearance for Clinical Development of UCART19

March 9, 2017

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

On March 9, 2017 Pfizer and Cellectis announced that FDA has granted Servier investigational new drug (IND) clearance to proceed with clinical development of UCART19, an allogeneic, gene-edited cellular therapy candidate to treat relapsed/refractory acute lymphoblastic leukemia, in the United States. Servier is sponsoring the CALM Phase I study on UCART19. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being co-developed by Servier and Pfizer.

The CALM study was initiated in the UK in August 2016. CALM is an open label, dose-escalation study designed to evaluate safety, tolerability, and anti-leukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

The allogeneic UCART19 candidate and CALM protocol were reviewed at the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) meeting on Dec. 14, 2016. Servier submitted an IND application on Feb. 1, 2017, with Pfizer’s support. According to a statement, with this IND clearance, the CALM study will be expanded to include several centers in the US, including the MD Anderson Cancer Center in Houston (Texas).

“We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR T therapy,” said Patrick Thérasse, director of Clinical Development Oncology at Servier in a statement. “B-ALL is a devastating disease and this study is key to gaining greater insight into the efficacy and safety profile of this new immune-oncology approach in patients with B-ALL.”

Source: Pfizer, Cellectis, and Servier