The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-SLAMF7 bispecific antibody fresh peripheral blood mononuclear cells (SLAMF7 FPBMC/CS1 FPBMC) for patients with relapsed and/or refractory multiple myeloma. Patients receive 8 weekly doses and then 8 more doses every 2 weeks of SLAMF7 FPBMC by intravenous infusion.
Once subjects are determined eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The white blood cells, specifically T cells, are then mixed with two proteins, OKT3 and IL-2, which activate the cells to multiply. The "activated" T cells are coated with the OKT3 and elotuzumab (an anti-SLAMF7 drug) to produce bispecific fresh peripheral blood mononuclear cells (FPBMC). About 72 hours after the leukapheresis procedure, SLAMF7 FPBMC infusions will start. After about 8-9 weeks, participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses. Before, throughout and following SLAMF7 FPBMC, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participants will receive 8 weekly infusions of SLAMF7 FPBMC, then 8 additional infusions every 2 weeks.
Ashley Donihee
Charlottesville, Virginia, United States
Dose-limiting toxicities (DLTs)
An adverse event that is considered at least possibly related to SLAMF7 FPBMC and meets at least one of the protocol-defined criteria
Time frame: From time of informed consent through one week following 8th FPBMC infusion
Adverse event profile
Severity, frequency, category, seriousness and duration of adverse events
Time frame: From time of informed consent through 30 days following last FPBMC infusion
Overall response rate (ORR)
As defined by International Myeloma Working Group (IMWG) response criteria (partial response (PR), very good partial response (VGPR), complete response (CR), stringent CR (sCR)
Time frame: About once a month during study treatment (for about 6 months), then about every 3 months for 3 years or until first progression
Minimal Residual Disease (MRD) status
Assessed by ClonoSeq, only for patients who achieve stringent CR or CR
Time frame: Through first progression of disease (maximum of 3 years from first infusion)
Overall Survival (OS)
Duration of time from consent through death or 3 years after first FPBMC infusion
Time frame: Through 3 years after first FPBMC infusion
Cellular anti-myeloma responses
IFN-gamma Elispots stimulated by a multiple myeloma cell line
Time frame: Multiple timepoints through 12 months after last FPBMC infusion
Progression-free survival (PFS)
Duration of time from consent through first progression (or end of follow-up)
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Time frame: From informed consent through first progression or 3 years after enrollment
Humoral anti-myeloma responses
Anti-SOX2 IgG antibodies in the serum by specific ELISA
Time frame: Multiple timepoints through 12 months after last FPBMC infusion
Lymphocyte response following infusions of SLAMF7 FPBMC
T cell count and count for T cell subpopulations
Time frame: Blood samples collected prior to first infusion and then before the second through fifth infusions