Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months

GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today presented updated results from the clinical investigator-initiated trial (IIT) of GC012F for treatment of newly diagnosed multiple myeloma (NDMM) as an oral presentation at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place in San Diego, California and online.

GC012F demonstrated a 100% overall response rate (ORR) and 95% MRD- sCR rate among 22 transplant-eligible, high-risk NDMM patients as of the data cutoff date of October 1, 2023. The data included longer-term follow-up from the initial 16 patients, for whom earlier results were presented at the 2022 American Society for Hematology (ASH) Annual Meeting, plus six additional patients that were enrolled and treated later. The data also showed that GC012F was well-tolerated with no new safety signals observed in this frontline application of CAR-T therapy.

“We are delighted to announce the updated data of FasTCAR-T GC012F for the treatment of multiple myeloma patients in the frontline setting. The clinical data continue to highlight the depth of response and highly favorable safety profile delivered by GC012F, as well as the greatly shortened manufacturing turnaround time, demonstrating the compelling benefits of our innovative dual-targeting approach and the FasTCAR next-day manufacturing technology,” said Dr. Wendy Li, Gracell’s Chief Medical Officer. “This dataset further strengthens the growing clinical evidence supporting the considerable potential of FasTCAR-T GC012F and underscores our dedication to pioneering breakthroughs in cell therapy.”

In the ongoing single-arm, open label, Phase 1 IIT, patients with NDMM were enrolled and treated with GC012F at three dose levels. All patients had one or more high-risk features, of which 91% (20/22) were classified as Stage II or III based on the Revised International Staging System (R-ISS), and 55% (12/22) had extramedullary plasmacytoma.

As of the data cutoff date of October 1, 2023 and with a median follow-up of 18.8 months (range: 6.6-28.4 months), the 22 evaluable patients achieved strong response rates following GC012F infusion:

100% (22/22) ORR;
95% (21/22) sCR;
100% (22/22) MRD-, as assessed by Euroflow at a sensitivity of 10-6;
Median duration of response (DOR) and median progression free survival (PFS) were not reached at the data cutoff date.
GC012F continued to show a favorable safety profile in the longer-term follow-up with no new safety findings:

Only 27% (6/22) patients experienced cytokine release syndrome (CRS), all of which were low-grade, either Grade 1 (23%, 5/22) or Grade 2 (5%, 1/22) and resolved within four days;
No CRS of any grade occurred in the remaining 73% (16/22) of patients;
No immune effector cell-associated toxicity (ICANS) or neurotoxicity of any grade occurred.

https://ir.gracellbio.com/news-releases/news-release-details/gracell-biotechnologies-presents-updated-clinical-data-fastcar-t