Cellectis files first clinical trial application for UCART19, for hematological malignancies

UCART19 is an allogeneic gene edited CAR T-cell product.

This study aims to include CD19-positive Acute Lymphoblastic Leukemia (ALL) patients. Other eligibility criteria to enter clinical trials will be assessed by the investigators.

“It has been a privilege preparing this application with our team, partners, investigators and subcontractors, in close interaction with MHRA, rewarding many years of intense work to overcome the challenges that are inherent to advanced therapy medicinal products. This achievement marks an important step toward making UCART19 available to patients,” said Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.

"The UCART19 CTA filing is a great recognition for the company’s preclinical and manufacturing accomplishments in developing a therapeutic for Acute Lymphoblastic Leukemia. We are all pleased with Cellectis’ progress to date with UCART19, including the filing of this CTA, and we look forward to following the progress of this program through the course of its clinical development," said Dr Mathieu Simon, EVP, Chief Operating Officer, Cellectis.