An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
IBI346 Antibody and IBI346 CAR-T cell injection
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Dose limiting toxicity (DLT)
Time frame: 21 days post IBI346 administration
Incidence and severity of adverse events: Proportion of subjects with treatment-related adverse events assessed by NCI-CTCAE v5.0 criteria
Time frame: 2 years post IBI346 administration
Presence or absence of replication-competent lentivirus (RCL)
Time frame: Baseline up to 15 years
Objective Response Rate (ORR)
Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working Group response criteria(2016)
Time frame: 3 months post IBI346 administration
Duration of Response (DOR)
DOR will be calculated among responders (with a PR or better response) from the date of initial response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2016).
Time frame: 2 years post IBI346 administration
Progression-free Survival (PFS)
PFS defined as time from date of initial administration of IBI346 to date of first disease progression according to IMWG criteria (2016), or death due to any cause, whichever occurs first.
Time frame: 2 years post IBI346 administration
Overall Survival (OS)
OS is measured from the date of the initial administration of IBI346 to the date of the subject's death.
Time frame: 2 years post IBI346 administration
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Pharmacokinetics parameters of IBI346 cells -Maximum CAR level in blood (Cmax)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells -Time to peak CAR level in blood (Tmax)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 cells - Area under the curve of the CAR level in blood (AUC)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Peak Plasma Concentration (Cmax)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- Area under the plasma concentration versus time curve (AUC)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- clearance (CL)
Time frame: 2 years post IBI346 administration
Pharmacokinetics parameters of IBI346 antibody- half-life (t1/2)
Time frame: 2 years post IBI346 administration
Positive rate of human anti-P329G CAR antibody
Time frame: 2 years post IBI346 administration
Positive rate of anti-drug antibody (ADA) of P329G BCMA antibody
Time frame: 2 years post IBI346 administration