Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step in the development of innovative treatments for this condition.
Clinical Study Plans
The Shanghai-based biotech plans to initiate a single-arm, open, multi-center Phase I/II clinical study in China during the third quarter of this year. With IND approval already obtained in the United States in March, the company expects to kick off a Phase Ib/II clinical study for the drug with the same indication in the US during the second quarter of this year.
GC012F: Autologous CAR-T Therapy
GC012F is an autologous CAR-T therapy developed on Gracell’s award-winning FasTCAR manufacturing platform, which enables a 24-hour treatment turnaround. This rapid turnaround time is a significant advantage in the treatment of multiple myeloma, where timely intervention can be critical.
Regulatory and Clinical Milestones
The therapy was awarded an orphan drug designation from the US FDA for its potential against MM in November 2021. Gracell is currently assessing the candidate in multiple investigator-initiated trials (IIT) for indications including newly diagnosed MM and B-cell non-Hodgkin’s lymphoma. At the European Hematology Association 2022 Hybrid Congress, Gracell presented longer-term follow-up clinical data of GC012F in r/r MM, which showed a 100% minimal residual disease (MRD) negativity rate in all patients treated. This data highlights the potential of GC012F to significantly improve outcomes for patients with multiple myeloma.-Fineline Info & Tech
