The purpose of this study is to assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Drug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection; Other Name: Gemcitabine Hydrochloride for Injection, Zefei; Oxaliplatin for Injection, Aihen TQB2825 injection is Cluster of Differentiation 3 (CD3) and and Cluster of Differentiation 20 (CD20) bispecific antibody; Gemcitabine hydrochloride for injection is a cell cycle-specific antimetabolite; Oxaliplatin for Injection is a platinum chemotherapy drug.
Complete response rate (CR rate)
Percentage of subjects with complete (CR) per 2014 Lugano criteria.
Time frame: 1 year
Overall response rate (ORR)
Percentage of subjects with complete (CR) or partial response (PR) according to 2014 Lugano Criteria.
Time frame: 1 year
Progression-free survival (PFS)
Time from randomization or first dose to disease progression or death from any cause, whichever occurs first, as determined by the 2014 Lugano Criteria.
Time frame: 1 year
Duration of Response (DOR)
The time from first achievement of response, to disease progression or death from any cause, whichever comes first, was determined according to the 2014 Lugano criteria.
Time frame: 1 year
Time to Response (TTR)
Time from randomization or first dose of trial drug to the first evaluation of PR or CR, whichever occurs first.
Time frame: 1 year
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: 3 years
Half-life (t1/2)
Time required for the amount of drug in the body or blood concentration to be reduced by half.
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
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The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGAffiliated Cancer Hospital and insititute Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHubei Cancer Hospital (HBCH)
Wuhan, Hubei, China
NOT_YET_RECRUITING...and 14 more locations
Area under the plasma concentration-time curve (AUC0-last)
Area under the dynamic curve of plasma concentration over time.
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Apparent clearance (CL)
The rate at which the drug is cleared from the body.
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Apparent volume of distribution at terminal phase (Vz)
The volume of body fluid required to distribute the drug in the body according to the plasma drug concentration at this time after the drug distribution in the plasma and tissues has reached equilibrium.
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Trough plasma concentration (Cmin)
Maximum blood concentration achieved by drug administration.
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Anti-drug antibody (ADA ) incidence
Immunogenicity test: Anti-drug antibody (ADA ) incidence.
Time frame: 2 years