Clinical Trial Details
Back to clinical trials
Phase IIInterventional
A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
Protocol: STUDY00007276NCT: NCT06297226
Overview
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
Inclusion Criteria
- Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
- Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
- Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
- Participants must have measurable disease during screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
- Active or history of central nervous system involvement with MM.
- Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
- Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
- Other protocol-defined Inclusion/Exclusion criteria apply.
