This is a phase I clinical study to evaluate the safety and tolerability of C-4-29 in patients with relapsed or refractory multiple myeloma, and to obtain the maximum tolerated dose of C-4-29 and phase II Recommended dose.
This is a multi-center, single-arm, open-label study. The study plans to set up 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with relapsed or refractory multiple myeloma.C-4-29 cells will be infused to the subject by intravenous infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Drug: C-4-29 Cells; Administration method: intravenous infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Incidence of Adverse events after C-4-29 infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame: 28 days
Obtain the maximum tolerated dose of C-4-29 cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Time frame: 28 days
Objective response rate after C-4-29 infusion [Effectiveness]
Objective response rate includes sCR, CR, VGPR, PR, MR
Time frame: 3 months
AUCS of C-4-29 cells [Cell dynamics]
AUCS is defined as the area under the curve in 28 days
Time frame: 3 months
CMAX of C-4-29 cells [Cell dynamics]
CMAX is defined as the highest concentration of C-4-29 cells expanded in peripheral blood
Time frame: 3 months
TMAX of C-4-29 cells [Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Time frame: 3 months
Peripheral blood M protein contents after C-4-29 infusion [Cell dynamics]
Periodic detection of Peripheral blood M protein after cell infusion
Time frame: 3 months
Urine Bence-Jones protein contents after C-4-29 infusion [Cell dynamics]
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Periodic detection of Urine Bence-Jones protein after cell infusion
Time frame: 3 months
Immunogenicity of C-4-29 cells
Anti-CAR antibody
Time frame: 3 months