| TITRE |
(EN) 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 |
| CLINICAL TRIAL.gov ID |
NCT06297226 |
| TYPE(S) DE CANCER |
Myélome |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Chaim Shustik Michael Sebag
|
| COORDONATEUR(RICE) |
Nancy Renouf
nancy.renouf@muhc.mcgill.ca
514-934-1934 poste 35718
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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.
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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.
|
