Cellectis, Servier, Pfizer report Phase I data for CAR T therapy in adult B-ALL

Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS), Servier (Neuilly-sur-Seine, France) and Pfizer Inc. (NYSE:PFE) reported preliminary data from seven evaluable adult patients with relapsed or refractory CD19-positive B cell acute lymphoblastic leukemia (B-ALL) in the Phase I CALM trial showing that five patients treated with UCART19 achieved molecular remission at day 28, defined as negative minimal residual disease (MRD). Cytokine release syndrome (CRS) was mild and manageable, except in one patient treated at the first UCART19 dose level who developed grade 4 CRS and neutropenic sepsis leading to death at day 15. No severe neurotoxicity was reported. Data were presented at the American Society of Hematology meeting in Atlanta.

The open-label, dose-escalation, international trial is enrolling about 40 patients. The primary endpoint is to evaluate dose-limiting toxicities (DLTs). Secondary endpoints include safety, objective response rate (ORR), duration of response, time to response, progression-free survival (PFS) and disease-specific survival...