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QUINTESSENTIAL-2, a phase 3 trial of arlocabtagene autoleucel (arlo-cel) for the treatment of RRMM1,2
NCT06615479
Key Inclusion Criteria2
- Documented diagnosis of MM as per International Myeloma Working Group Criteria with measurable disease
- Adult patients who received 1-3 prior MM regimens, which may include a PI, an IMiD, and an
anti-CD38 monoclonal antibody, and have prior exposure to lenalidomide
Key Exclusion Criteria2,3
- Patients who have known active or history of central nervous system involvement of MM
- Patients who have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease
- Patients who received prior GPRC5D-directed therapy
QUINTESSENTIAL-2 Trial Schema3
A phase 3 trial where arlo-cel is compared to 2 different standard-of-care treatments
Mandatory bridging therapy with DPd or Kd initiated within 6 days of randomization. Once arlo-cel is manufactured and available to the treatment center, the patient will undergo pretreatment evaluation to ensure they remain eligible to receive lymphodepletion and arlo-cel infusion.
Primary Endpoints1:
- Progression-free survival
- MRD negativity in complete response
Select Secondary Endpoints1:
- Overall survival
- Overall response rate
- MRD negativity status
- Complete response rate
- Time to response
- Duration of response
- Pharmacokinetics
- Patient-reported quality of life outcomes
- Safety
For further details on this trial, visit ClinicalTrials.gov >
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Explore Arlo-cel Clinical Trials
Arlo-cel phase 2 study4
Arlo-cel phase 3 study1,2
GPRC5D=G protein-coupled receptor, class C, group 5, member D; IMiD=immunomodulatory drug; MM=multiple myeloma; MRD=minimal residual disease; PI=proteasome inhibitor; RRMM=relapsed/refractory multiple myeloma.
References: 1. Popat R, Larson SM, Varshavsky-Yanovsky A, et al. QUINTESSENTIAL-2: a phase 3 study comparing efficacy and safety of arlocabtagene autoleucel (arlo-cel) versus standard regimens in adult patients with relapsed or refractory multiple myeloma (RRMM) refractory to lenalidomide. J Clin Oncol. 2025;43(16)(suppl):TPS7564. doi:10.1200/JCO.2025.43.16_suppl.TPS7564 2. A study to compare the efficacy and safety of BMS-986393 versus standard regimens in adult participants with relapsed or refractory and lenalidomide-exposed multiple myeloma (QUINTESSENTIAL-2). ClinicalTrials.gov identifier: NCT06615479. Updated February 10, 2026. Accessed February 13, 2026. https://clinicaltrials.gov/study/NCT06615479 3. Popat R, Larson SM, Varshavsky-Yanovsky A, et al. Trial in progress: QUINTESSENTIAL-2—a phase 3 study of arlocabtagene autoleucel versus standard of care in adult patients with relapsed and refractory multiple myeloma (RRMM) exposed to lenalidomide. Poster presented at: International Myeloma Society (IMS) Annual Meeting; September 17-20, 2025; Toronto, Canada. Poster PA-079. 4. Study of arlocabtagene autoleucel (BMS-986393) a GPRC5D-directed CAR T cell therapy in adult participants with relapsed or refractory multiple myeloma (QUINTESSENTIAL). ClinicalTrials.gov identifier: NCT06297226. Updated February 10, 2026. Accessed February 13, 2026. https://clinicaltrials.gov/study/NCT06297226