This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.
The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously
Institute of Hematology and Blood Diseases Hospital
Tianjin, China
RECRUITING[phase Ib] Incidence and severity of Adverse Events
Incidence and severity of Adverse Events
Time frame: 24 months
[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion
the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Time frame: 3 months
Overall response rate (ORR)
The rate of patients with best response of partial response (PR) or better
Time frame: 24 months
[phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion
The rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Time frame: 3 months
Duration of response (DOR)
The time from the first documented PR or better response to relapse or death, whichever occurs first
Time frame: 24 months
Time to response (TTR)
The time from the date of C-CAR088 infusion to the first documented PR or better
Time frame: 24 months
Progression-free survival (PFS)
The time from the date of C-CAR088 infusion to the date of first documented disease progression or death
Time frame: 24 months
Overall survival (OS)
The time from the date of C-CAR088 infusion to the date of death
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Time frame: 24 months
Minimal residual disease (MRD) negativity rate
The rate of patients reached MRD negativity
Time frame: 24 months
[phase II] Incidence and severity of Adverse Events
Incidence and severity of Adverse Events
Time frame: 24 months
Maximal plasma concentration (Cmax)
maximal plasma concentration of C-CAR088 in peripheral blood
Time frame: 24 months
Time to reach the maximal plasma concentration (Tmax)
Time to reach the maximal plasma concentration of C-CAR088 in peripheral blood
Time frame: 24 months
Area under the curve within 28 days (AUC0-28d)
Area under the curve of C-CAR088 in peripheral blood within 28 days post infusion
Time frame: 28 days
Time of last measurable observed concentration (Tlast)
Time of last measurable observed concentration of C-CAR088 in peripheral blood
Time frame: 24 months
Anti-drug (C-CAR088) antibody
Presence of serum anti-drug (C-CAR088) antibody
Time frame: 24 months
Serum M protein
serum M proteins concentration changes over time
Time frame: 24 months
Urine M protein
Urine M proteins concentration changes over time
Time frame: 24 months
Serum free light chain (sFLC)
Serum free light chain (sFLC) concentration changes over time
Time frame: 24 months