Gracell Biotechnologies Receives FDA Clearance of IND Application for Phase 1b/2 Clinical Trial

Gracell Biotechnologies (Nasdaq: GRCL), a global clinical-stage biopharmaceutical company, has received FDA clearance for its IND application, clearing the company to initiate a clinical trial to evaluate an autologous CAR-T therapeutic candidate for the treatment of relapsed/refractory multiple myeloma (RRMM).

Gracell’s lead candidate, GC012F, has demonstrated deep responses and a favorable safety profile across indications. The company says it shows strong potential to become a transformative therapy.

Highlights

• The Phase 1b portion of the trial will evaluate the safety and tolerability of GC012F in RRMM patients and determine the recommended dose of GC012F for Phase 2.
• The Phase 2 portion of the trial is intended to evaluate the efficacy of GC012F in RRMM patients and further characterize the safety of GC012F.
• Gracell plans to initiate its Phase 1b/2 clinical trial in the U.S. in the second quarter of 2023.
• The FDA granted GC012F Orphan Drug Designation for the treatment of multiple myeloma in November 2021.

Gracell’s autologous and allogeneic product candidates have the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality and high therapy cost.

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform will potentially be available using next-day manufacturing and have demonstrated enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities in preclinical studies.