New CAR t therapy targets Hard-to-Treat myeloma
NCT ID NCT06297226
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This study tests a new treatment called arlocabtagene autoleucel (BMS-986393) for adults with multiple myeloma that has come back or not responded to other treatments. The therapy uses a patient's own immune cells, modified to attack cancer cells. The study aims to see if this treatment can shrink tumors and how safe it is. About 230 participants will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
49 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arthur J.E. Child Comprehensive Cancer Centre
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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Banner MD Anderson Cancer Center
RECRUITINGGilbert, Arizona, 85234, United States
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Chiba University Hospital
RECRUITINGChiba, 260-8677, Japan
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Colorado Blood Cancer Institute
RECRUITINGDenver, Colorado, 80218, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Hyogo Medical University Hospital
RECRUITINGNishinomiya, Hyōgo, 663-8501, Japan
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Japanese Red Cross Medical Center
RECRUITINGShibuya-ku, Tokyo, 150-8935, Japan
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LDS Hospital
RECRUITINGSalt Lake City, Utah, 84143, United States
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Local Institution - 0065
WITHDRAWNBaltimore, Maryland, 21218, United States
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Local Institution - 0067
WITHDRAWNCharlotte, North Carolina, 28204, United States
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Local Institution - 0069
WITHDRAWNAustin, Texas, 78704, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic in Rochester, Minnesota
RECRUITINGRochester, Minnesota, 55905, United States
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McGill University Health Centre
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute
RECRUITINGSan Antonio, Texas, 78229, United States
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Miami Cancer Institute at Baptist Health, Inc.
RECRUITINGMiami, Florida, 33176, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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Nagoya City University Hospital
RECRUITINGNagoya, Aichi-ken, 467-8602, Japan
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Northside Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
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Northwestern Memorial Hospital
RECRUITINGChicago, Illinois, 60611, United States
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Norton Women's and Children's Hospital
RECRUITINGLouisville, Kentucky, 40207, United States
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Oncology Hematology Care
RECRUITINGCincinnati, Ohio, 45242, United States
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Oregon Health and Science University
RECRUITINGPortland, Oregon, 97239, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Royal Brisbane and Women's Hospital
RECRUITINGBrisbane, Queensland, 4029, Australia
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, New South Wales, 2050, Australia
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Rutgers Cancer Institute of New Jersey
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Sidney Kimmel Cancer Center - Jefferson Health
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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St Vincent's Hospital
RECRUITINGMelbourne, Victoria, 3065, Australia
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Tennessee Oncology
RECRUITINGNashville, Tennessee, 37203, United States
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The Alfred Hospital
RECRUITINGMelbourne, Victoria, 3004, Australia
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The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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The University of Kansas Cancer Center - Westwood
RECRUITINGWestwood, Kansas, 66205, United States
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UCLA Hematology/Oncology - Westwood (Building 200 Suite 214)
RECRUITINGLos Angeles, California, 90095, United States
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UCSF Helen Diller Medical Center at Parnassus Heights
RECRUITINGSan Francisco, California, 94143, United States
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UT Southwestern Medical Center
RECRUITINGDallas, Texas, 75390, United States
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University Hospital,Kyoto Prefectural University of Medicine
RECRUITINGKyoto, 602-8566, Japan
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35294-3300, United States
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University of Arkansas for Medical Sciences
RECRUITINGLittle Rock, Arkansas, 72205, United States
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University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
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University of Iowa
RECRUITINGIowa City, Iowa, 52242, United States
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University of North Carolina Medical Center
RECRUITINGChapel Hill, North Carolina, 27599-7305, United States
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University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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Virginia Oncology Associates
RECRUITINGNorfolk, Virginia, 23502, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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Winship Cancer Institute of Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?