Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in refractory systemic lupus erythematosus, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells
FasTCAR-T GC012F has demonstrated deep responses and a favorable safety profile in clinical investigator-initiated trials (IIT) in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma (B-NHL)
“We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr.
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 addition to the upcoming rSLE IND study, GC012F is being evaluated in the Phase 1b/2 IND study for the treatment of relapsed/refractory multiple myeloma (RRMM) in the
The Phase 1 portion of the Phase 1/2 clinical trial evaluating GC012F in rSLE will be initiated in 2024 and is designed to assess the safety and tolerability of GC012F, determine the recommended dose for Phase 2 study and characterize the pharmacokinetics of GC012F in this patient population.
Systemic lupus erythematosus (SLE) is a B-cell-mediated autoimmune disease, in which autoantibodies produced by the immune system attack the patient’s own tissues, causing multi-organ damage. While immunosuppressants are used as the current standard of care, SLE remains a chronic condition that is difficult to manage, significantly impacts quality of life, and has no cure. There is an urgent, high unmet medical need for more effective – and even curative – therapies, particularly to help manage rSLE.
Several patient case studies in academia have shown CD19 CAR-T cell therapy to be feasible, tolerable and highly effective in a number of autoimmune diseases, including SLE. By targeting both CD19 and BCMA, it is believed that GC012F could enable deeper and wider depletion of disease-causing B-cells and plasma cells, potentially offering a more effective and longer-lasting therapeutic approach for rSLE. Further, in preclinical studies, GC012F has shown a more effective elimination of antibody secreting cells compared to CD19 single-targeted CAR-T therapy.
About GC012F
GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with an improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of RRMM in
About FasTCAR
Introduced in 2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of therapy for cancer and autoimmune diseases, and improve outcomes for patients by enhancing effect, reducing costs, and enabling more patients to access critical CAR-T treatment. FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells. In 2022 and 2023, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards and the Overall Immunology Solution of 2023 by BioTech Breakthrough Awards, for its ability to address major industry obstacles.
About Gracell
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Media ContactsMarvin Tang marvin.tang@gracellbio.comJessica Laub jessica.laub@westwicke.com Investor ContactsGracie Tong gracie.tong@gracellbio.comStephanie Carrington stephanie.carrington@westwicke.com
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