A Clinical Trial to Explore the Safety and Efficacy of CT071 injection in Patients with Relapsed/Refractory Multiple Myeloma or Primary Plasma Cell Leukemia
This trial is a single-arm, open-label, dose-finding, first-in-human clinical trial. The main aim of this study is to preliminarily evaluate the safety and tolerability of CT071 after infusion, and explore the dose range of CT071 in patients with relapsed/refractory multiple myeloma or primary plasma cell leukemia, so as to determine the possible recommended therapeutic dose (RD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Biological: chimeric antigen receptor T cells
Shanghai Changzheng Hospital
Shanghai, China
DLT after CT071 infusion
Evaluate DLT and adverse events after CT071 infusion
Time frame: Assessed from the date of first dose of study treatment until 21~28 days
AE of Neurotoxicity and cytokine release syndrome after CT071 infusion
Cytokine release syndrome(CRS)should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading,higher scores mean a worse outcome.
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
Adverse Events (AE) after CT071 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cellassociated neurotoxicity syndrome (ICANS).
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Level of CAR-T Cell Expansion (proliferation), and Persistence
Levels of cell expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.
Time frame: From first dose of study drug administration to 26 weeks
Cytokines in the peripheral blood after CT071 infusion
Serum concentrations of interleukin (IL)-2, IL-6,IL-8,IL-10,interferon-gamma (IFN-γ), and TNF-α after CT071 infusion
Time frame: From first dose of study drug administration to 4 weeks
Preliminary evaluation of immunogenicity
ADA positive rate
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
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Overall response rate (ORR) as measured by International Myeloma Working Group (IMWG) criteria after CT071 infusion
ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Rate of very good partial response (VGPR) and above, complete response/stringent complete response (CR/sCR);
Rate of very good partial response (VGPR) and above defined as proportion of patients achieving VGPR or better based on IMWG defined response criteria; Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on IMWG defined response criteria.
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Duration of response (DOR)
DOR is defined as the time from first achieving PR or better to confirmed disease progression or death from any cause.
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Minimal residual disease (MRD) negative rate;
Minimal residual disease (MRD) negative rate is defined as the proportion of patients with VGPR or better who achieved 10-5 sensitivity of nucleated cell.
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Time to response (TTR)
TTR defined as the time from the date of apheresis to the date of initial assessment of PR or better in patients with a best response assessment of partial response or better according to IMWG2016 criteria.
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Progression-free survival (PFS)
PFS defined as the time from the date of apheresis of the subject to the first assessment of confirmed disease progression or death from any cause according to IMWG2016 criteria, whichever occurs first.
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Overall survival (OS)
OS defined as the time from the date of apheresis of the subject to death from any cause.
Time frame: From first dose of study drug administration to death