This is a single-arm, open-label, dose-finding Phase I/II clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT1190B cells in patients with R/R LBCL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
68 subjects received 1190B injection for infusion
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 编辑译文 段落对照
Hubei, Wuhan, China
treatment-emergent adverse events (TEAE),
Time frame: Infusion until 12 months
treatment-related adverse events (TRAE)
Time frame: Infusion until 12 months
•serious adverse events (SAE), and adverse events of special interest (AESI)
Time frame: Infusion until 12 months
Dose limiting toxicity (DLT)
Time frame: Infusion until 12 months
maximum tolerated dose (MTD
Time frame: Infusion until 12 months
recommended phase 2 dose (RP2D)
Time frame: Infusion until 12 months
ORR
Time frame: Infusion up to 12 months
Objective response rate (ORR) at 12 weeks
Time frame: Infusion until 12 weeks
CRR
Time frame: Infusion up to 12 months
DOR
Time frame: Infusion up to 12 months
TTR
Time frame: Infusion up to 12 months
TTCR
Time frame: Infusion until 12 months
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PFS
Time frame: Infusion up to 180 months
OS
Time frame: Infusion up to 180 months
Time to maximum expansion (Tmax),
Time frame: Infusion up to 12 months
maximum expansion concentration (Cmax)
Time frame: Infusion up to 12 months
concentration-time curve (AUC)
Time frame: Infusion up to 12 months
sustained cell survival time (Tlast)
Time frame: Infusion up to 12 months
Cytokine level
Time frame: Infusion up to 12 months
Anti-drug antibody (ADA) level
Time frame: Infusion up to 12 months