bluebird bio has started treating patients in a Phase I clinical trial (CRB-402) of its investigational candidate bb21217 for relapsed or refractory multiple myeloma.
bb21217 is a chimeric antigen receptor T cell (CAR T) therapy being developed in partnership with Celgene to target B cell maturation antigen (BCMA).
Under the collaboration, Celgene has exercised its option to exclusively licence bb21217 and will make a $15m option exercise payment to bluebird bio.
The Phase I trial will include a dose-escalation portion during, which patients will be administered with increasing doses of bb21217 to establish a maximum tolerated dose and recommended Phase II dose.
A dose expansion portion is also included in the trial for further assessment of bb21217’s safety, tolerability, and clinical activity when given at the recommended Phase II dose.
bluebird bio chief scientific officer Philip Gregory said: “bb21217, bluebird’s second oncology programme to enter the clinic, complements bb2121, which has demonstrated encouraging safety and efficacy results in an ongoing Phase I trial.
“With bb21217, we manufacture a CAR T cell product enriched for memory T cells, a long-lived, more potent T cell subtype, which in preclinical in vivo studies has shown improved anti-tumour activity.”
The CRB-402 trial’s primary objective is an evaluation of the maximum tolerated dose and determination of the recommended Phase II dose, while the secondary objective is a measurement of preliminary efficacy data.
Following the Phase I trial, Celgene will be responsible for bb21217’s world-wide development and commercialisation.