This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.
This is a single arm, open-label, dose escalation investigator initiated (IIT) study, the primary objective is to evaluate the safety and tolerability of CD19/ CD22/BCMA CAR-T therapy in patients with relapsed/refractory multiple myeloma, and determine the maximum tolerated dose (MTD). For the secondary objectives,pharmacokinetics(PK), survival of CAR-T cells in vivo,pharmacodynamics (PD) and efficacy in R/R MM will be evaluated. This study flow comprises of a screening phase( 30 to10 days prior to infusion), apheresis phase (9 to 8 days prior to infusion), lymphodepletion phase (5 to 3 days prior to infusion) , infusion of CD19/CD22/BCMA CAR-T cells on Day0, DLT assessments phase (from Day1 to Day 28) and post- treatment follow-up phase (Day 29 and up to end of the study).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CD19/CD20/BCMA CAR T therapy
China, Shanghai Mengchao Cancer Hospital
Shanghai, China
RECRUITINGDose-limiting toxicity(DLT)
Safety
Time frame: [Time Frame: Day0-Day28]
Maximum tolerated dose (MTD)
Evaluate the incidence, severity, and correlation of SAE Tolerability
Time frame: [Time Frame: Day0-Day28]
Maximum Plasma Concentration(Cmax)
Pharmacokinetics(PK)
Time frame: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
Maximum Plasma Concentration Time (Tmax)
Pharmacokinetics(PK)
Time frame: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
Area Under Curve (AUC)
Pharmacokinetics(PK)
Time frame: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
CAR positive T cells
Pharmacokinetics(PK)
Time frame: [Time Frame: Day0-Day28#Day0-undetectable for CAR positive T cells]
Cytokines ( IL(interleukin)-2)
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
Cytokines ( IL(interleukin)-4)
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
Cytokines ( IL(interleukin)-6)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
Cytokines ( IL(interleukin)-8)
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
Cytokines ( IL(interleukin)-10)
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
Cytokines ( IL(interleukin)-15)
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
IFN(interferon)-γ
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
TNF(tumor necrosis factor)-α
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
MCP( monocyte chemoattractant protein)-1)
Pharmacodynamics (PD)
Time frame: [Time Frame:Day0-Day28]
Overall survival (OS)
Based on the analysis of MRD negative rate by researchers according to IMWG standards
Time frame: [Time Frame: Day28,Month2,Month3,Month6,Month9,Month12,Month15,Month18,Month21,Month24]
Progression-free survival (PFS)
Based on the analysis of MRD negative rate by researchers according to IMWG standards
Time frame: [Time Frame: Day28,Month2,Month3,Month6,Month9,Month12,Month15,Month18,Month21,Month24]
Minor residual diseases(MRD)
Based on the analysis of MRD negative rate by researchers according to IMWG standards
Time frame: [Time Frame: Day28,Month2,Month3,Month6,Month9,Month12,Month15,Month18,Month21,Month24]