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Recruiting Phase 2 NCT06297226

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

Phase 2 – studying effectiveness and dosage
Conditions: Multiple Myeloma

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

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Overview
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.
Who can participate
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.
Locations 4
Australia (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Joy Ho, Site 0077
Canada (1)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary , Alberta
Nizar Bahlis, Site 0020
Japan (1)
Nagoya City University Hospital
Nagoya , Aichi-ken
Shinsuke Iida, Site 0057
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Susan Bal, Site 0001
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
21.03.2024
Completion date
30.06.2032
Registry ID
NCT06297226
Source
anzctr
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