Gracell Biotechnologies starts dosing in US Phase 1b/2 trial assessing GC012F's efficacy for treating recurrent or resistant multiple myeloma

Gracell Biotechnologies Inc., a worldwide clinical-stage biopharmaceutical company committed to creating potent and groundbreaking cell therapies for cancer and autoimmune disease management, has announced that the initial patient in the US has begun treatment in a Phase 1b/2 clinical trial for it's foremost candidate, GC012F, targeting patients with recurrent or resistant multiple myeloma.

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The company's unique autologous therapeutic candidate, GC012F, dual-targets B cell maturation antigen(BCMA) and CD19,. This has been made possible through its unique FasTCAR next-day manufacturing platform. 

The initial portion of the open-label multi-center study, Phase 1b, has commenced and will unfold at some of the most prestigious medical institutions in the US. This study anticipates involving around 12 subjects at two distinct dosage levels. The primary aim of this study is to analyze GC012F's safety and tolerability in RRMM patients, arrive at the optimal dose for Phase 2, and understand the pharmacokinetics of GC012F in RRMM patients. The subsequent phase, Phase 2, is designed to gauge GC012F's efficacy in RRMM patients and to further verify its safety.

Impressive results have been gathered by Gracell, supporting the dual-targeting mechanism of GC012F in treating RRMM, said Dr. William Cao, founder, Chairman, and CEO of Gracell. Based on its former clinical studies, which showed immediate, significant, and enduring responses, and its distinct safety profile, we are confident that GC012F has the capability to emerge as a leading treatment regimen, bringing benefits to patients across stages of the disease.

GC012F has been a subject of research for over 50 patients across RRMM, newly identified multiple myeloma, and B-cell non-Hodgkin's lymphoma in investigator-led trials. These have shown rapid, significant, and long-lasting responses. It is also under consideration for treating refractory systemic lupus erythematosus, as assessed in an investigator-initiated trial (IIT).

Most recent clinical data about GC012F, in dealing with RRMM treatment, has been communicated at the ASCO and EHA annual meetings. According to the data cut-off of April 12, 2023, GC012F has facilitated a 93.1% overall response rate (ORR) within a proportion of 29 predominantly high-risk RRMM patients. A stringent complete response rate of 82.8% has been reported, with an average of 38 months of progression-free survival.

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According to the data provided by the Synapse Database, As of October 3, 2023, there are 15 investigational drugs for the BCMA and CD19 target, including 15 indications,16 R&D institutions involved, with related clinical trials reaching 43，and as many as 6990 patents.

GC012F is a dual-functioning autologous CAR-T cell therapy developed by Gracell that targets BCMA/CD19 and is powered by its FasTCAR technology. The impetus behind this therapy is to revolutionize the way we treat cancer and autoimmune diseases by eliciting quicker, more profound, and longer-lasting responses, all while maintaining a favorable safety record. As of now, GC012F's potential is being tested in clinical trials for various hematological malignancies and autoimmune disorders, where it continues to display remarkable efficacy and safety.