Bluebird Bio and Celgene Corp. reported positive results from the ongoing phase 1 trial evaluating bb2121, an investigational anti-B cell maturation antigen chimeric antigen receptor T-cell therapy, in patients with relapsed/refractory multiple myeloma.
The primary endpoint of the study is incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities. It also aims to determine disease-specific response criteria such as complete response, very good partial response and partial response.
In addition, the trial was designed to decide the recommended dose for further clinical trials.
Based on the latest updated results, 100% of the 15 evaluable patients in the active dose cohorts achieved an objective response. Meanwhile, 73% of the evaluable patients in the active dose cohorts achieved a very good partial response or better.
The study also recorded an 89% overall response rate across all cohorts, with a 27% complete response rate across active dose cohorts.
As of the May 4 data cutoff, there was no disease progression observed in the active dose cohorts.
Bluebird and Celgene entered a collaboration in March 2013 to develop chimeric antigen receptor T cell therapies to target and destroy cancer cells. The agreement was amended to focus on the development of product candidates targeting B-cell maturation antigen in June 2015.