This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.
Subjects with relapsed/refractory multiple myeloma or plasma cell leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility including disease assessments, a physical exam, Electrocardiograph, Computed tomography (CT)/Magnetic Resonance Imaging (MRI)/Positron Emission Tomography (PET), liver/renal function tests, complete blood count with differential and complete metabolic profile and etc. Subjects will receive preconditioning chemotherapy prior to the first infusion of human BCMA targeted CAR-NK Cells injection. After the infusion, subjects will be followed for adverse events, pharmacokinetic/pharmacodynamics characteristics, efficacy of human BCMA targeted CAR-NK cells. Study procedures may be performed while hospitalized.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Allogenic genetically modified anti-BCMA CAR transduced NK cells
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDose limited toxicity (DLT)
Safety Indicators
Time frame: 28 days post infusion
Pharmacokinetics parameters - the highest concentration of human BCMA targeted CAR-NK cells amplified in peripheral blood and bone marrow after infusion
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacokinetics parameters - the time to reach the highest concentration of human BCMA targeted CAR-NK cells amplified in peripheral blood and bone marrow after infusion
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacokinetics parameters - the 28-day area under the curve of human BCMA targeted CAR-NK cells amplified in peripheral blood and bone marrow after infusion
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacodynamics characteristics - the detection values of CRP, IL-6, IL-15, Granzyme B cytokines in peripheral blood
Effectiveness Metrics
Time frame: 2 years post infusion
Pharmacodynamics characteristics - the detection values of monoclonal plasma cell in bone marrow
Effectiveness Metrics
Time frame: 2 years post infusion
Overall response rate (ORR, include PR, VGPR, CR and sCR) after administration
Effectiveness Metrics
Time frame: 3 months post infusion
Percentage of subjects with negative minimal residual disease (MRD)
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Effectiveness Metrics
Time frame: 2 years post infusion
Duration of subjects with negative minimal residual disease (MRD)
Effectiveness Metrics
Time frame: 2 years post infusion
Number of subjects with adverse events
Safety Metrics
Time frame: 2 years post infusion
Change from baseline in perform status as measured by Easten Cooperative Oncology Group (ECOG) score
2 years post infusion
Time frame: Safety Metrics
The occurrence rate of adverse events grade≥3 assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Safety Metrics
Time frame: 2 years post infusion
Change in body weight over time after infusion
Safety Metrics
Time frame: 2 years post infusion
Duration of remission (DOR) after administration
Effectiveness Metrics
Time frame: 2 years post infusion
Overall Survival (OS) after administration
Effectiveness Metrics
Time frame: 2 years post infusion