Posted: Monday, March 13, 2023
According to early findings presented in the journal Blood, therapy with GC012F, an autologous B-cell maturation antigen (BCMA) and CD19 dual-targeting chimeric antigen receptor (CAR) T-cell therapy developed on the novel FasTCAR-T platform, demonstrated a favorable safety profile and activity in patients with high-risk, newly diagnosed multiple myeloma. This novel immunotherapy yielded a 100% overall response rate and a 100% rate of measurable residual disease (MRD) negativity, concluded Weijun Fu, PhD, of the Changzheng Hospital and Naval Medical University, Shanghai, and colleagues.
“The promising preliminary results warrant further assessment of GC012F for [transplantation-eligible newly diagnosed multiple myeloma] with more patients and longer follow-up,” the authors said.
In this phase I study, the authors enrolled 13 patients with transplantation-eligible, high-risk, newly diagnosed multiple myeloma who received GC012F infusions. The median time from diagnosis to infusion was 4.5 months. All patients had one or more high-risk features. Of the group, 12 patients received two cycles of induction therapy with bortezomib, lenalidomide, and dexamethasone, and one patient received one cycle of bortezomib, epirubicin, and dexamethasone and one cycle of bortezomib, lenalidomide, and dexamethasone prior to infusion. GC012F was administered as a single fusion at three dose levels.
After a median follow-up of 5.3 months, 100% of patients achieved a very good partial response or better, whereas 69% of patients had a stringent complete response. All four patients who received dose-level 2 (2 x 105/kg) and 50% of patients who received dose-level 3 (3 x 105/kg) achieved an MRD-negative complete response after infusion.
The authors found there was no apparent difference among MRD negativity when comparing dose levels. Cytokine-release syndrome occurred in three patients, with no treatment-related grade 3 or higher cytokine-release syndrome and immune effector cell–associated neurotoxicity syndrome events.
Disclosure: The study authors reported no conflicts of interest.