BCMA/CD19 dual-targeting FasTCAR-T GC012F demonstrated 100% ORR and 100% MRD negativity in the 13 patients treated
GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and is developed using Gracell's proprietary FasTCAR next-day manufacturing platform.
As of the ASH abstract data cutoff date
The study is ongoing. As of the ASH abstract data cutoff date, among the 13 efficacy-evaluable patients with a median follow-up time of 5.3 months (range 2.3-12.5 months):
- Overall response rate was 100%
- 69% of patients had achieved stringent complete response (sCR). Patients continue to be followed for deepening responses
- All patients had achieved minimal residual disease (MRD) negativity
- In the MRD assessment with EuroFlow for landmark analysis at month 1 and month 6, all evaluable patients were MRD negative at both timepoints
- All patients had experienced robust CAR-T cell expansion
The preliminary clinical data is also demonstrating an excellent safety profile:
- Only 23% (3/13) patients experienced Grade 1-2 cytokine release syndrome (CRS)
- No Grade 3 or higher CRS, and no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade had been observed
- Abstract title: Phase I Open-Label Single-Arm Study of BCMA/CD19 Dual-Targeting FasTCAR-T Cells (GC012F) As First-Line Therapy for Transplant-Eligible Newly Diagnosed High-Risk Multiple Myeloma
- Abstract ID: 162295
Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR T in Multiple Myeloma and T-cell Therapies After Allo-HCT
- Session Date:
Saturday, Dec. 10, 2022from 4-5:30 p.m. CT
- Presentation Time: 5:15 p.m. CT
- Location: Ernest N. Morial Convention Center, Great Hall A/D
The abstract is now available online on the ASH website.
"We are excited to present the first clinical data evaluating GC012F as a first-line therapy for multiple myeloma at ASH 2022, a premier gathering of leading minds in hematology and oncology from around the world. We are thrilled to report that BCMA/CD19 dual targeting FasTCAR-T GC012F is showing a very favorable safety profile and encouraging efficacy in newly-diagnosed multiple myeloma patients," said Dr.
GC012F is a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in
CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, and, together with fast release time, enables enhanced accessibility of cell therapies for cancer patients.
Cautionary Noted Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the
View original content to download multimedia:https://www.prnewswire.com/news-releases/gracell-biotechnologies-to-present-first-clinical-data-of-fastcar-t-gc012f-for-newly-diagnosed-multiple-myeloma-at-64th-american-society-of-hematology-annual-meeting--exposition-301667106.html