This is a single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma or plasmacytic leukemia.
This study is divided into two stages: dose escalation and dose extension. The "3+3" dose escalation design was adopted in the dose escalation stage, and three dose escalation dose groups of 1.0×10\^5 CART(Chimeric Antigen Receptor T Cell) cells/kg, 3.0×10\^5 CART cells/kg and 6.0×10\^5 CART cells/kg were preset. Each dose group level included 3-6 subjects with a single dose. The objective is to preliminarily observe the safety and tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma (RRMM) or plasma cell leukemia, and provide evidence for dose expansion phase. In the dose expansion phase, 1 to 2 dose groups were selected for expansion based on the dose escalation phase, and 3 to 6 subjects were included in each extended dose group to further evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of RD140 injection in the treatment of RRMM or plasma cell leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
This study is divided into two stages: dose escalation and dose extension. The dose escalation stage sampled the "3+3" dose-escalation design, and set up three dose-increasing dose groups of 1.0×10\^5 CART cells/kg, 3.0×10\^5 CART cells/kg and 6.0×10\^5 CART cells/kg, and subjects will receive a single infusion of RD140. Each dose group level will include 3-6 subjects. In the dose expansion stage, 1\~2 dose groups were selected for expansion and 3\~6 subjects were included in each extended dose group, and the target dose was administered once.
Adverse Events
Type and incidence of adverse events (AEs)
Time frame: 2 years after CAR-T cell infusion
Overall response rate (ORR)
Proportion of subjects who achieved sCR, CR, VGPR, and PR after receiving study therapy
Time frame: Up to 2 years post RD140 infusion
Duration of Response (DOR)
Time from first response to disease progression or death from any cause
Time frame: Up to 2 years post RD140 infusion
Progression-free Survival (PFS)
Time from RD140 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Time frame: Up to 2 years post RD140 infusion
Overall Survival (OS)
Time from RD140 infusion to time of death due to any cause
Time frame: Through study completion,up to 15 years post RD140 infusion
Time to Response (TTR)
Time from RD140 infusion to first documentation of response
Time frame: Up to 2 years post RD140 infusion
Time to Complete Response (TTCR)
Time from RD140 infusion to first documentation of Complete Response or better response
Time frame: Up to 2 years post RD140 infusion
Minimal Residual Disease (MRD)
Proportion of subjects who achieved MRD negative
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Time frame: Up to 2 years post RD140 infusion
Duration of MRD negativity
The time from the first MRD negative to the first MRD negative positive transfer
Time frame: Up to 2 years post RD140 infusion
Pharmacokinetics - Cmax
The maximum transgene level at Tmax
Time frame: Up to 2 years post RD140 infusion
Pharmacokinetics - Tmax
Time to peak transgene level
Time frame: Up to 2 years post RD140 infusion
Pharmacokinetics - Area Under the Curve (AUC)
Area under the curve of 28, 90, 180 days and the last time point of PK detection (AUC0-28d, AUC0-90d, AUC0-180d, AUC0-last)
Time frame: Up to 2 years post RD140 infusion
soluble BCMA levels
soluble BCMA levels in peripheral blood of subjects
Time frame: Up to 2 years post RD140 infusion
C-reactive protein (CRP)
Changes in the levels of CRP
Time frame: Up to 3 months post RD140 infusion
Ferritin
Changes in the levels of Ferritin
Time frame: Up to 3 months post RD140 infusion
Interleukin-6 (IL-6)
Changes in the levels of IL-6
Time frame: Up to 3 months post RD140 infusion