French-based biopharmaceutical company Cellectis has treated the first patient in the Phase I trial of its UCART19 to treat pediatric acute B lymphoblastic leukemia (B-ALL).
UCART19 is the company's allogeneic CAR T-cell product candidate, developed to treat CD19-expressing hematological malignancies and gene edited with TALEN®.
TALEN® is a monomeric compact product based on Cellectis' patented TAL effector nuclease technology. It requires the expression of only one DNA or RNA molecule to be active.
The open label, non-comparative and single-centre pediatric Phase I trial is sponsored by Servier in close collaboration with Pfizer.
It is designed to assess the safety and efficacy of UCART19 to facilitate molecular remission in pediatric patients afflicted with elapsed or refractory CD19, positive B-cell, acute lymphoblastic leukemia ahead of planned allogeneic haematopoeitic stem-cell transplantation (allo-HSCT).
UCART19 is initially being developed in chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).
Initial clinical trials of UCART19 using autologous products based on the CAR technology has demonstrated the ability to overcome the limitations of the current autologous method by offering an allogeneic, frozen, off-the-shelf T cell based medicinal product.
Servier has assumed the exclusive rights for UCART19 from Cellectis, while Pfizer has secured exclusive rights from Servier to develop and market the product in US.
After further agreements, Servier and Pfizer has started cooperating on a joint clinical development programme for Cellectis' cancer immunotherapy.