Gracell Reveals Encouraging Data From Pretreated Multiple Myeloma Patients

Gracell Biotechnologies Inc GRCL announced the updated clinical data on GC012F, an autologous CAR-T therapeutic candidate dual-targeting B-cell maturation antigen (BCMA) and CD19, for relapsed/refractory multiple myeloma (RRMM).
From October 2019 to January 2022, 29 heavily pretreated patients were enrolled and treated with a single infusion of GC012F at three dose levels (DL).
At the data cutoff of June 8, 2022, the response rate at different dose levels was 100% (2/2) in DL1, 80% (8/10) in DL2, and 100% (17/17) in DL3.
All 29 patients achieved minimal residual disease (MRD) negativity. 75.9% of all patients treated achieved MRD-sCR. At the data cutoff, the median duration of response (DOR) was 15.7 months.
The safety profile of GC012F was consistent with previous findings with a primarily low grade of cytokine release syndrome (CRS).
Additionally, Gracell presented the first results of Phase 1 investigator-initiated study in China of GC012F in B-cell non-Hodgkin's lymphoma patients.
All three patients achieved a complete response (CR) confirmed at day 28 after GC012F infusion.
At the 3-month follow-up, both assessable patients had an ongoing response. No dose-limiting toxicities and immune effector cell-associated neurotoxicity syndrome were observed.
CRS presented as Grade 1 in two patients and Grade 3 in one patient with no Grade 4 or 5 events.
Price Action: GRCL shares are down 13.11% at $2.86 on the last check Monday.