CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
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)
This study is testing a new CAR T cell therapy to see if it can help adults with multiple myeloma who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored |
| Locations | 52 sites (Birmingham, Alabama and 51 other locations) |
| Trial ID | NCT06297226 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393), a CAR T cell therapy targeting GPRC5D, in adults with relapsed or refractory multiple myeloma. Participants must have a documented diagnosis of multiple myeloma and have undergone at least three prior lines of therapy. The study aims to assess how well this innovative treatment can manage the disease in patients who have not responded to previous treatments.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have received multiple lines of prior therapy.
Not a fit: Patients with active central nervous system involvement or those who have received prior therapies targeting GPRC5D may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies using CAR T cell therapies have shown promising results in treating multiple myeloma, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 51 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) — Los Angeles, California, United States (Recruiting)
- UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States (Recruiting)
- Colorado Blood Cancer Institute — Denver, Colorado, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (Recruiting)
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (Recruiting)
- Norton Women's and Children's Hospital — Louisville, Kentucky, United States (Recruiting)
- Local Institution - 0065 — Baltimore, Maryland, United States (Withdrawn)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (Recruiting)
- Local Institution - 0067 — Charlotte, North Carolina, United States (Withdrawn)
- Oncology Hematology Care — Cincinnati, Ohio, United States (Recruiting)
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- Local Institution - 0070 — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Local Institution - 0069 — Austin, Texas, United States (Withdrawn)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute — San Antonio, Texas, United States (Recruiting)
- LDS Hospital — Salt Lake City, Utah, United States (Recruiting)
- Virginia Oncology Associates — Norfolk, Virginia, United States (Recruiting)
- Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)
- University Hospital and UW Health Clinics — Madison, Wisconsin, United States (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Recruiting)
- St Vincent's Hospital — Melbourne, Victoria, Australia (Recruiting)
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
- Nagoya City University Hospital — Nagoya, Aichi-ken, Japan (Recruiting)
- Hyogo Medical University Hospital — Nishinomiya, Hyōgo, Japan (Recruiting)
- Chiba University Hospital — Chiba, Japan (Recruiting)
+2 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.