This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL
This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL. During the trial, dose increases or decreases or dose expansion may be performed using i3+3 principle based on the safety and ,tolerability and PK data of the patients. All Patients will undergo a DLT assessment period which is defined as the first 28 days starting from the day of CT0596 infusion. A patient is evaluable for DLTs if the patient received the planned CT0596 dose and either completed the 28 days of DLT evaluation period after CT0596 infusion or experienced a DLT. Enrolled patients who are not evaluable for DLTs during dose escalation may be replaced. Any Patients who are not DLT evaluable will still be followed for safety and efficacy per the SOA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
chimeric antigen receptor T cells
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 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
MTD 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 CR or better based on 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 IMWG defined response criteria
Time frame: 12 months after CT0596 infusion
Duration of response (DOR)
DOR is defined as the time from first achieving PR or better to confirmed disease progression or death from any cause
Time frame: 12 months after CT0596 infusion
Minimal residual disease (MRD) negative rate
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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)
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)
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 IMWG2016 criteria, whichever occurs first.
Time frame: 12 months after CT0596 infusion
Peak value of CART cells
Time to peak expansion and peak expansion in plasma after infusion of CT0596 cells
Time frame: 12 months after CT0596 infusion
Overall survival (OS)
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
Area under the plasma concentration versus time curve (AUC) of CART cells
Area under the plasma concentration versus time curve (AUC) in plasma after infusion of CT0596 cells
Time frame: 12 months after CT0596 infusion
In vivo persistence of CART cells
CART cells duration in plasma after infusion of CT0596 cells
Time frame: 12 months after CT0596 infusion