This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 in the peri-transplant setting in MM patients with minimal residual disease (MRD+) in first or second remission.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Single dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Dose limiting toxicities following Combination Product administration
Time frame: 90-100 days post Combination Product administration
Incidence and severity of side effects related to the Combination Product
Time frame: 90-100 days post Combination Product administration
Rate of MRD (by ClonoSEQ®) conversion from positive to negative at 90-100 days after transplantation
Time frame: 90-100 days post-ASCT
Rate of MRD conversion from positive to negative
Time frame: 1 year post-ASCT
Rate of MRD conversion from positive to negative at any time during the maintenance phase
Time frame: Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)
Rate of PFS
Time frame: 1 year post Combination Product administration
Rate of OS
Time frame: 1 year post Combination Product administration
Best overall response rate per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Time frame: 90-100 days post-ASCT, 1 year post-ASCT, and overall during maintenance phase (approximately 3 years)
Incidence and severity of cytokine release syndrome per ASBMT consensus grading
Time frame: 100 days post Combination Product administration
Incidence and severity of other Immune-related toxicities by CTCAE version 5.0
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Time frame: 100 days post Combination Product administration
PK of BHV-1100 by determining plasma Tmax
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmax
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmin
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma AUC
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma t1/2
Time frame: 4 days post Combination Product administration