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Chimeric antigen receptor modified T cells chimeric antigen receptor T cells

Chimeric antigen receptor modified T cells Infusion

Juan Du

Juan Du, PhD

This trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma.

This trial is a single-arm, single-center, open-label clinical trial to evaluate the safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly diagnosed multiple myeloma (HRNDMM).

Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma

Exploratory Clinical Trial of the Safety and Efficacy of CT071 Injection in Patients With High Risk Newly Diagnosed Multiple Myeloma

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 cell-associated neurotoxicity syndrome (ICANS).

ORR defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria

Evaluate Dose limited toxicity and adverse events after CT071 infusion

Minimal residual disease (MRD) negative rate is defined as the proportion of patients with Very good partial response or better who achieved 10-5 sensitivity of nucleated cell

Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on International Myeloma Working Group defined response criteria

DOR is defined as the time from first achieving partial response or better to confirmed disease progression or death from any cause

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 International Myeloma Working Group 2016 criteria, whichever occurs first

TTR defined as the time from the date of apheresis to the date of initial assessment of Partial response or better according to International Myeloma Working Group 2016 criteria

TTBR defined as the time from the date of apheresis to the date of assessment with a best response according to International Myeloma Working Group 2016 criteria

OS defined as the time from the date of apheresis of the subject to death from any cause

Serum concentrations of granulocyte-macrophage colony stimulating factor (GM-CSF) interleukin (IL)-6, IL-10, interferon gamma (IFN-γ) and tumor necrosis factor (TNF),after CT071 infusion

Serum concentrations of C-reactive protein (CRP),etc.

Area under the plasma concentration versus time curve (AUC)

Levels of cell expansion persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.

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