Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

Recruiting now · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06297226

Run by

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

People needed

230

Starts

2024-03-21

Expected to finish

2032-06-30

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (enrolling)
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (enrolling)
• UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco, California, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) — Los Angeles, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (enrolling)
• Norton Women's and Children's Hospital — Louisville, Kentucky, United States (enrolling)
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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