US-based clinical-stage cell therapy company AvenCell Therapeutics, Inc. confirmed on Thursday that the US Food and Drug Administration and the European Medicines Agency have cleared its Investigational New Drug application and approved its clinical trial application, respectively, for QUADvance (AVC-203-01), a phase I/II study for the treatment of relapsed/refractory B-cell malignancies.

AVC-203 is a CRISPR-engineered, allogeneic CAR-T therapy designed to target CD19 and/or CD20 receptors, which are present on nearly all B-cell malignancies.

The company plans to begin a Phase I/II study across multiple sites in the US and Europe to assess safety, tolerability, efficacy and pharmacokinetics in adults with relapsed or refractory B-cell cancers. A phase Ia dose escalation study is expected to be followed by a phase Ib dose expansion study and a Phase II pivotal trial.

AvenCell says this allogeneic, off-the-shelf approach could overcome scalability, consistency and cost challenges seen with traditional autologous CAR-T therapies.