Cellectis seeks approval for UCART19 clinical trials
Cellectis has submitted a clinical trial application (CTA) to UK regulators for permission to begin first-in-human studies of UCART19, a gene-edited cell therapy, for leukemia treatment.
Cellectis, a gene therapy company, has submitted a clinical trial application (CTA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval to initiate first-in-human clinical investigations of UCART19, an allogeneic gene-edited CAR T-cell product, for the treatment of acute lymphoblastic leukemia (ALL).
The planned study intends to enroll patients with CD19-positive ALL. Other eligibility criteria will be determined by the investigators. If approved, this submission represents a significant step toward making UCART19 available to patients.
UCART19 is designed to treat CD19-expressing hematological malignancies and utilizes Cellectis' TALEN® gene-editing technology. Allogeneic CAR T-cells offer a potential advantage over autologous approaches by providing a standardized, frozen, "off-the-shelf" T-cell product that can be readily administered.
In November 2015, partner Servier exercised its option to license UCART19 and entered a collaboration with Pfizer. Under this agreement, Servier and Pfizer will manage the clinical development of UCART19, relieving Cellectis of responsibility for funding the Phase I clinical program.