TQB3820 is a novel cereblon-modulating agent. Upon binding to cereblon, a substrate receptor in the cullin4 E3 ligase complex, TQB3820 promotes recruitment, ubiquitination, and subsequent proteasomal degradation of the hematopoietic transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). Modulation of Aiolos and Ikaros expression has the potential to correct multiple aspects of the immune dysregulation mediated by B cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
TQB3820 is a novel cereblon-modulating agent.
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGInstitute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Time frame: up to 18 months
Maximum Tolerated Dose (MTD)
The maximum Dose at which less than 33% subjects experiencing DLT
Time frame: up to 18 months
Recommended Phase II Dose (RP2D)
RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating pharmacokinetics (PK) data
Time frame: up to 18 months
Adverse Events (AEs)
Type, frequency, seriousness and severity of adverse events and laboratory abnormalities, such as hyperuricemia.
Time frame: Baseline up to 24 months
Maximum (peak) plasma drug concentration (Cmax)
Maximum plasma concentration of drug
Time frame: Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
Time to reach maximum(peak )plasma concentration following drug administration (Tmax)
Time to Maximum plasma concentration of drug
Time frame: Hour 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
Elimination half-life (t1/2)
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Terminal-phase elimination half life
Time frame: Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0 (pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28)
Overall response rate (ORR)
The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate in MM The sum of percentage of participants with complete response rate, partial response rate for B-NHL
Time frame: Baseline up to 24 months
Clinical benefit rate (CBR)
The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate, minimal response rate in MM
Time frame: Baseline up to 24 months
Time to response (TTR)
Time from the first date of dose to the first date of documented response (partial response \[PR\] or greater).
Time frame: Baseline up to 24 months
Duration of Response (DOR)
Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD) or death from any cause, whichever occurs first
Time frame: Baseline up to 24 months
Progression-free survival (PFS)
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
Time frame: Baseline up to 24 months
Overall survival (OS)
Time from the first dose to death due to any cause
Time frame: Baseline up to 24 months