This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
This is an open-label, single arm, dose-escalation clinical study, to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CT0594CP
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSafety and tolerability dose limiting toxicity
Safety and tolerability: dose limiting toxicity \[Time Frame: 21-28 days post administration of CT0594CP \]
Time frame: 21-28 days
Pharmacokinetics of CT0594CP CAR-T Cells (Tmax)
peak plasma Concentration time(Tmax), of after infusion CT0594CP CAR T Cells
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
Pharmacokinetics of CT0594CP CAR-T Cells (Cmax)
peak plasma Concentration(Cmax), of after infusion CT0594CP CAR T Cells
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
Pharmacokinetics of CT0594CP CAR-T Cells (AUC)
area under the Plasma concentration versus time curve (AUC), of after infusion CT0594CP CAR T Cells
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
To evaluate the overall safety and tolerability of CT0594CP
Post-treatment Adverse events (TEAE) and incidence, Special Concern Adverse Events (AESI) and incidence, treatment-related adverse events
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
To evaluate the initial efficacy of CT0594CP infusion in target subjects
Overall response rate (ORR)、 Complete response/strict complete response (CR/sCR) rate、Response rates of VGPR and above were achieved 、Duration of response (DOR)、Progression-free survival (PFS)、Overall survival (overall survival (OS)、Minimal residual disease (MRD) negative rate as measured by International Myeloma Working Group (IMWG) criteria after CT0594CP infusion
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Time frame: From first dose of study drug administration to end of treatment (up to 12 months)