Clinical Trials in Australia / 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 Australia 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 Australia
Other trials for the same condition
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 Australia