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Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Friday, January 13, 2023
Juan Du, MD, of Shanghai Changzheng Hospital, the Second Military Medical University, China, and colleagues performed a phase I study evaluating the use of GC012F—an autologous B-cell maturation antigen (BCMA) and CD19 dual-targeting chimeric antigen receptor (CAR) T-cell therapy—in patients with newly diagnosed multiple myeloma. Presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 366), the results of this study demonstrated anticancer activity.
“In this phase I study for transplant-eligible, newly diagnosed, high-risk multiple myeloma, GC012F showed a very favorable safety profile, high efficacy with 100% overall response rate, and 100% [measurable] residual disease negativity [MRD],” the authors concluded. “The promising preliminary results warrant further assessment of GC012F in [this population] with more patients and longer follow-up.”
The investigators focused on 13 patients with high-risk, newly diagnosed multiple myeloma who were eligible for transplantation. Participants received two cycles of bortezomib, dexamethasone, and lenalidomide (n = 12) or one cycle of bortezomib, epirubicin, and dexamethasone and one cycle of the former (n = 1), followed by a single GC012F infusion at one of three dose levels.
With a median follow-up of 5.3 months, 100% of patients achieved a very good partial response or better, and 69% reached a stringent complete response. There did not appear to be any differences observed in MRD negativity between dose levels. However, 50% of individuals at dose level 3 achieved MRD-negative/stringent complete response after infusion, likely because of their increased frequency of high-risk factors, according to the investigators.
At 1 month and 6 months after infusion, 100% of patients achieved MRD negativity. Three patients experienced grade 1 (n = 2) or grade 2 (n = 1) cytokine-release syndrome. Of note, grade 3 or higher cytokine-release syndrome and immune effector cell–associated neurotoxicity syndrome events were not reported.
Disclosure: The study authors reported no conflicts of interest.
2022 ASH Annual Meeting and Exposition
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