CAR-T Therapy for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).
Research Team
Sergio Giralt, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Marcelo C Pasquini, MD, MS
Principal Investigator
Medical College of Wisconsin
Alfred Garfall, MD
Principal Investigator
University of Pennsylvannia
Eligibility Criteria
Adults over 18 with symptomatic multiple myeloma who've had autologous hematopoietic cell transplant within the last year, are on a lenalidomide maintenance regimen, and have good organ function. They must not be pregnant or breastfeeding and agree to use two forms of birth control. Excluded are those with certain medical conditions, previous gene or BCMA-targeted therapies, uncontrolled infections, or unwillingness to follow study protocols.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis and Manufacturing
Patients undergo leukapheresis for collection of autologous lymphocytes, which are sent to manufacturing facilities
Lymphodepleting Chemotherapy
Patients receive cyclophosphamide and fludarabine for 3 consecutive days
CAR T-cell Infusion
Infusion of BCMA CAR T-cells at a target dose of 450 x106 cells
Maintenance Therapy
Maintenance lenalidomide is initiated and continues until 12 months post CAR T-cell infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- bb2121
- Lenalidomide
bb2121 is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma
- Relapsed or refractory multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marcelo Pasquini, MD
Lead Sponsor
National Marrow Donor Program
Collaborator
National Cancer Institute (NCI)
Collaborator
Blood and Marrow Transplant Clinical Trials Network
Collaborator
Celgene a wholly owned subsidiary of BMS
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator