NEW YORK – Gracell Biotechnologies on Friday said it will begin evaluating the investigational FasTCAR-T GC012F in a Phase Ib/II trial involving relapsed or refractory multiple myeloma patients.
The firm said that the US Food and Drug Administration has cleared its investigational new drug application, giving Gracell the go-ahead to begin its planned trial during the second quarter of 2023.
The San Diego-based firm will evaluate the safety, recommended dose, and pharmacokinetics of GC012F as well as its initial efficacy. The autologous cell therapy, which Gracell says it can manufacture in a day, targets both the CD19 antigen and the B-cell maturation antigen (BCMA) on the surface of cancer cells. The cell therapy, which has orphan drug designation from the FDA, is undergoing multiple investigator-initiated trials involving patients with relapsed or refractory multiple myeloma, newly diagnosed multiple myeloma, or B-cell non-Hodgkin lymphoma.
Gracell recently presented data from one such trial, showing that relapsed or refractory multiple myeloma patients on GC012F had a 100 percent minimal residual disease negativity rate.
"Advancing our lead therapeutic candidate into a US clinical trial is a major milestone for Gracell and further validates our GC012F program, proprietary FasTCAR next-day manufacturing platform, and novel dual-targeted approach," Gracell Founder, CEO, and Chairman William Cao said in a statement. "Having demonstrated deep responses and a favorable safety profile across indications, GC012F continues showing strong potential to become a transformative therapy."