Clinical Trials in Japan / NCT06297226
Recruiting
Phase 2
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma
NCT06297226 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Multiple Myeloma
Investigational drug(s) / intervention(s)
Arlocabtagene Autoleucel: Specified dose on specified days
Study summary
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
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.
Primary outcome measure(s)
- Cohort 1: Best overall response (BOR) of partial response (PR) or better — Up to approximately 5 years
The number and percent of participants achieving BOR of partial response (PR) or better in quadruple class exposed participants received at least 4 prior lines of therapy (LOT)
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | Recruiting |
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) | Los Angeles | California | Recruiting |
| UCSF Helen Diller Medical Center at Parnassus Heights | San Francisco | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | Recruiting |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | Recruiting |
| Northside Hospital | Atlanta | Georgia | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| The University of Kansas Cancer Center - Westwood | Westwood | Kansas | Recruiting |
| Norton Women's and Children's Hospital | Louisville | Kentucky | Recruiting |
| Local Institution - 0065 | Baltimore | Maryland | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | Recruiting |
| Local Institution - 0067 | Charlotte | North Carolina | Withdrawn |
| Oncology Hematology Care | Cincinnati | Ohio | Recruiting |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | Recruiting |
| Oregon Health and Science University | Portland | Oregon | Recruiting |
| Sidney Kimmel Cancer Center - Jefferson Health | Philadelphia | Pennsylvania | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Local Institution - 0069 | Austin | Texas | Withdrawn |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Methodist HealthCare System of San Antonio Clinical Trials Office, Texas Transplant Institute | San Antonio | Texas | Recruiting |
| LDS Hospital | Salt Lake City | Utah | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
+ 12 more sites — see the full list on the official registry below.
More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in Japan
Other trials for the same condition
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06297226 on ClinicalTrials.gov ↗ ← All trials in Japan