BMS Reports Positive Phase 2 CAR T Cell Trial Results

Princeton, New Jersey, U.S., September 8, 2026

QUINTESSENTIAL Trial Meets Key Efficacy Endpoints

The QUINTESSENTIAL trial (NCT06297226) is a Phase 2, open-label, multicenter, single-arm registrational study evaluating the efficacy and safety of arlo-cel in adults with quadruple-class exposed RRMM. The patient population had received at least four prior lines of therapy and had been treated with an immunomodulatory drug (IMiD), proteasome inhibitor, anti-CD38 therapy and BCMA-targeted therapy. The trial also included patients who had previously received CAR T-cell therapy. BMS reported that the study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful overall response rate among quadruple-class exposed patients who had received four or more prior lines of therapy. The trial also met its key secondary endpoint of complete response rate in the same population. Additional key secondary endpoints evaluating ORR and CRR among patients who had received three or more prior lines of therapy were also met. The company said the safety profile of arlo-cel was consistent with expectations for CAR T-cell therapies and other GPRC5D-targeting therapies in multiple myeloma. Detailed results from the study are expected to be presented at an upcoming medical meeting.

GPRC5D Targeting Offers an Alternative to BCMA

Arlocabtagene autoleucel is designed as an autologous GPRC5D-directed CAR T-cell therapy, representing a potentially differentiated approach for patients whose disease has progressed following multiple established treatment classes. GPRC5D is expressed on plasma cells involved in multiple myeloma and represents a therapeutic target distinct from B-cell maturation antigen (BCMA). The distinction is particularly important in patients previously exposed to BCMA-directed treatments. According to BMS, GPRC5D expression is independent of BCMA expression and can remain present following prior BCMA-directed therapy, providing a biological rationale for targeting GPRC5D in patients with disease that has become resistant to BCMA-directed approaches. As a CAR T-cell therapy, arlo-cel is intended to be administered as a single infusion following a treatment process involving collection of the patient’s T cells, bridging therapy when required, CAR T-cell manufacturing, lymphodepleting chemotherapy and subsequent administration and monitoring.

Potential New Option for Heavily Pretreated Multiple Myeloma

The findings could be important for the growing population of patients with relapsed and refractory multiple myeloma who have exhausted several major therapeutic classes. Increasing use of combination regimens in earlier treatment lines means patients may become exposed to multiple drug classes sooner, potentially resulting in treatment resistance and limited options later in the disease course. The positive QUINTESSENTIAL results position arlo-cel as a potential new treatment approach for patients previously exposed to BCMA-targeted therapy, while also advancing BMS’s broader cell-therapy pipeline. However, the therapy remains investigational, and the company has not yet established regulatory approval for this indication. BMS has stated that the complete QUINTESSENTIAL results will be presented at an upcoming medical meeting. Regulatory approval, if pursued, will depend on review of the complete clinical evidence.

Source: Bristol Myers Squibb press release