Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma
BCMA/CD19 dual-targeting FasTCAR-T GC012F has demonstrated deep responses and favorable safety profile in proof of concept clinical studies
Company plans to initiate Phase 1b/2 clinical trial in the U.S. in second quarter of 2023
Excerpt from the Press Release:
SAN DIEGO Calif., and SUZHOU and SHANGHAI, China, Feb. 3, 2023 /PRNewswire/ — Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application and the Company can proceed to initiate a Phase 1b/2 clinical trial in the U.S. of GC012F, an autologous CAR-T therapeutic candidate, for the treatment of relapsed/refractory multiple myeloma (RRMM).
GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform. In November 2021, the FDA granted GC012F Orphan Drug Designation for the treatment of multiple myeloma. GC012F is currently being studied in multiple investigator-initiated trials (IIT) evaluating its safety and efficacy in RRMM, newly-diagnosed multiple myeloma, 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 RRMM that showed a 100% minimal residual disease (MRD) negativity rate in all patients treated.
Gracell plans to initiate a Phase 1b/2 clinical trial in the second quarter of 2023 in the U.S. to further evaluate GC012F in RRMM patients. The Phase 1b portion of the trial is designed to evaluate the safety and tolerability of GC012F in RRMM patients, determine the recommended dose of GC012F for Phase 2 and characterize the pharmacokinetics of GC012F in RRMM patients. The Phase 2 portion is intended to evaluate the efficacy of GC012F in RRMM patients and further characterize the safety of GC012F.
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