Clinical Trials

Date: 2016-06-20

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: Cellectis (France) Servier (France)

Product: UCART19

Action mechanism:

cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. UCART19 is a potential best-in-class allogeneic TALEN® gene edited T-cell product for treatment of CD19 expressing hematological malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Engineered allogeneic CD19 CAR T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, “off the shelf” T-cell based medicinal product.
On November 18, 2015 Servier exercised its worldwide option to license UCART19 under a collaboration agreement. Cellectis also entered into a global development and commercialization collaboration with Pfizer on UCART19. According to their recent agreement, Cellectis will hand over the clinical development of UCART19 to Servier and their US partner Pfizer. Due to the early exercise, Cellectis is no longer responsible for funding the UCART19 Phase I clinical program.

Disease: relapsed/refractory B acute lymphoblastic leukaemia (ALL)

Therapeutic area: Cancer - Oncology

Country: UK

Trial details:

This phase 1, open label, non-comparative, monocenter study aims at evaluating the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) ahead of planned allogeneic hematopoietic stem cell transplantation (allo-HSCT). (NCT02808442)

Latest news:

* On June 20, 2016, Cellectis announced that the first patient has been treated in the Phase I study of UCART19 in pediatric acute B lymphoblastic leukemia (B-ALL) at the University College of London (UCL). This UCART19 clinical trial is sponsored by Servier in close collaboration with Pfizer. The pediatric Phase I is an open label, non-comparative, monocenter study to evaluate the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia ahead of planned allogeneic haematopoeitic stem cell transplantation (allo-HSCT). Cellectis will receive a milestone payment from Servier of an undisclosed amount.

* On December 23, 2015, Cellectis announced the submission of a clinical trial application (CTA) to the Medicines & Healthcare products Regulatory Agency (MHRA) requesting approval to initiate UCART19 First-inHuman clinical investigation in leukemia in the United Kingdom. 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.

Is general: Yes