A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
CAR-T cells Infusion chimeric antigen receptor T cells
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGAdverse Events (AE) after CT0596 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame: 12 months after CT0596 infusion]
Maximum tolerated dose and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion
Time frame: 12 months after CT0596 infusion
Overall response rate (ORR) as assessed by the investigator
Overall response rate (ORR) defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria
Time frame: 12 months after CT0596 infusion
Complete response/stringent complete response (CR/sCR) rate
Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving complete response or better based on International Myeloma Working Group( IMWG) defined response criteria.
Time frame: 12 months after CT0596 infusion
Rate of very good partial response (VGPR) and above
Rate of complete very good partial response response/stringent complete response (VGPR/CR/sCR) defined as proportion of patients achieving VGPR or better based on International Myeloma Working Group(IMWG) defined response criteria
Time frame: 12 months after CT0596 infusion
Duration of response (DOR)
Duration of response (DOR) is defined as the time from first achievingpartial response( PR )or better to confirmed disease progression or death from any cause
Time frame: 12 months after CT0596 infusion
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Minimal residual disease (MRD) negative rate
Minimal residual disease (MRD) negative rate is defined as the proportion of patients with VGPR or better who achieved 10-5 sensitivity of nucleated cell
Time frame: 12 months after CT0596 infusion
Time to response (TTR)
Time to response(TTR )defined as the time from the date of apheresis to the date of initial assessment of PR or better according to IMWG2016 criteria
Time frame: 12 months after CT0596 infusion
Progression-free survival (PFS)
Progression-free survival(PFS) defined as the time from the date of apheresis of the subject to the first assessment of confirmed disease progression or death from any cause according to International Myeloma Working Group( IMWG)2016 criteria, whichever occurs first.
Time frame: 12 months after CT0596 infusion
Test Copy number of CAR
Evaluate cellular pharmacokinetics of CT0596
Time frame: 12 months after CT0596 infusion]
Overall survival (OS)
Overall survival(OS) defined as the time from the date of apheresis of the subject to death from any cause
Time frame: 12 months after CT0596 infusion
Cytokines in the peripheral blood after CT0596 infusion
Serum concentrations of interleukin (IL)-6 after CT0596 infusion
Time frame: 12 months after CT0596 infusion]