Updates in Myeloma Treatment: BMS-986393 CAR T-Cell Therapy Shows Promise in Phase I Study for Relapsed/Refractory Patients
Dr. Susan Bal discusses update safety and efficacy data from a phase I, first-in-human, multicenter, open-label, dose-finding study evaluating BMS-986393 (CC‑95266), a GPRC5D-targeted autologous CAR T-cell therapy, in patients with relapsed/refractory multiple myeloma (RRMM).
Abstract title:
219 BMS-986393 (CC-95266), a G Protein–Coupled Receptor Class C Group 5 Member D (GPRC5D)–Targeted Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Multiple Myeloma (RRMM): Updated Results from a Phase 1 Study Presented at ASH 2023
What is the purpose of this trial?
This trial aims to find new and effective treatments for patients with relapsed/refractory multiple myeloma (RRMM). Despite progress in RRMM therapy, there is a need for innovative approaches for patients who experience a relapse. The study focuses on a promising target for multiple myeloma called GPRC5D, which is found on myeloma cells but has limited expression in other tissues.
The trial, known as CC-95266-MM-001 (NCT04674813), is a phase I study, marking the first time this investigational therapy, BMS-986393 (CC‑95266), is being tested in humans. It involves an autologous CAR T-cell therapy specifically designed to target GPRC5D.
Previously, the researchers shared interim results from the study's early phases. Now, they are presenting updated information on the safety and efficacy of BMS-986393. The goal is to understand how well this novel therapy works in treating RRMM and to assess any potential side effects.
This research contributes to the ongoing efforts to improve outcomes for patients facing RRMM, offering hope for a more effective and targeted treatment approach.
In this video:
Susan Bal, MD, (University of Alabama — Birmingham, AL) discusses this phase I trial that studies the investigational therapy BMS-9MS-986393 (CC‑95266) and its first-time use in humans.
Conclusion:
In this first-in-human study, BMS-986393 showed a manageable safety profile and deep and durable responses, including MRD negativity, at all tested dose levels, including in patients who are refractory to prior BCMA-directed therapies. Cytokine Release Syndrome (CRM) and ICANS-type neurotoxicity were mostly low-grade, with increased G ≥ 3 events at the 300 and 450 × 106 CAR T‑cell doses. On-target off-tumor treatment-related adverse side effects (TRAEs), all G1/2, occurred in a minority of patients. These data support GPRC5D-directed CAR T-cell therapy with BMS-986393 as a potential treatment in RRMM, irrespective of prior BCMA-directed therapy. Dose expansion is continuing to define the recommended phase II dose (RP2D). Updated data will be presented.
Trial information: Abstract #219
Doctor bio:
Susan Bal, MD, (University of Alabama — Birmingham, AL) is a dedicated hematologist specializing in plasma cell disorders, particularly light chain (AL) amyloidosis and multiple myeloma. With a focus on delivering comprehensive care, she is also fellowship-trained in performing stem cell transplantation and innovative cellular therapies, including chimeric antigen receptor (CAR) T cell therapies.
Dr. Bal is at the forefront of collaborative efforts with other subspecialty colleagues to initiate a groundbreaking interdisciplinary program in systemic AL Amyloidosis. This program, the first of its kind in Alabama, highlights her commitment to advancing specialized care and treatment options for patients with this complex condition.
