Titre |
A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma |
Protocole ID |
QUINTESSENTIAL |
ClinicalTrials.gov ID |
NCT06297226 |
Type(s) de cancer |
Myélome |
Phase |
Phase II |
Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
Type étude |
Clinique |
Médicament |
BMS-986393 |
Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
Ville |
Montréal |
Investigateur(trice) principal(e) |
Dr Chaim Shustik
Dr Michael Sebag
|
Coordonnateur(trice) |
Nancy Renouf
514-934-1934 poste 35718
|
Statut |
Actif en recrutement |
Critètes d'éligibilité |
- Documented diagnosis of multiple Mmyeloma (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, and anti-B cell maturation antigen (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.
- Participants must have measurable disease during screening.
- Have measurable disease during screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
|
Critètes d'exclusion |
- 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.
- 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.
|