Shanghai-based biotech Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the US FDA for its chimeric antigen receptor (CAR) T cell candidate GC012F. This dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step forward in the development of innovative treatments for this condition.
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. The platform was recently named “Life Sciences Innovation of 2022.” The therapy was awarded an orphan drug designation from the US FDA for its potential against multiple myeloma (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.
Clinical Data and Upcoming Trials
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 efficacy and safety of GC012F in treating r/r MM.
Gracell plans to initiate the US Phase Ib/II trial in Q2 2023. The Phase Ib portion will assess safety and tolerability and determine the recommended dose for Phase II, as well as the molecule’s pharmacokinetics. The Phase II portion is intended to evaluate the efficacy of GC012F in r/r MM patients and further characterize its safety profile.-Fineline Info & Tech
