This is a single-group, open, dose escalation and expansion Phase I clinical study, with phase I being a dose escalation study and Phase II being a dose expansion study. The purpose of this study was to evaluate the safety and tolerability of TQB2825 injection in CD20-positive hematological tumor subjects, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) (if any), or optimal biological dose (OBD), and recommended phase II dose (RP2D).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
TQB2825 injection is a bi-specific, humanized antibody against CD3×CD20, with the structure ratio of anti-CD3 to anti-CD20 of 1:2. It has two asymmetric Fab ends and a complete Fc end, and is a natural IgG4 subtype with weak antibody-dependent cell-mediated cytotoxicity or complement dependent cytotoxicityfunction. By bridging CD3 and CD20, TQB2825 injection induces T cell activation to promote T cell proliferation/expansion, promote the formation of cytolytic synapses, and cause cytotoxic T cells to release perforin and granase, thereby killing CD20 positive tumor cells. Therefore, TQB2825 injection is intended for the treatment of CD20 positive hematologic tumors, including but not limited to lymphoma, leukemia and myeloma.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose limiting toxicity(DLT)
To evaluate DLT of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Time frame: 104 weeks
the maximum tolerated dose (MTD)
To evaluate MTD of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Time frame: 104 weeks
Recommended Phase II Dose(RP2D)
To evaluate RP2D of TQB2825 injection in Chinese adult patients with CD20 positive hematological tumors.
Time frame: 104 weeks
Adverse events (AE)
The occurrence of all adverse events (AE)
Time frame: Baseline up to 104 weeks
serious adverse events (SAE)
serious adverse events (SAE)
Time frame: Baseline up to 104 weeks
treatment-related adverse events(TRAE)
treatment-related adverse events(TRAE)
Time frame: Baseline up to 104 weeks
Elimination half-life (to be used in one-or non- compartmental model) (t1/2)
t1/2 is time that takes for the blood concentration of TQB2825 or metabolite(s) to drop by half.
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Tmax
Time to reach maximum (peak) plasma concentration following drug administration(Tmax)
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Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Maximum (peak) plasma drug concentration (Cmax)
Cmax is the maximum plasma concentration of TQB2825.
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
To characterize the pharmacokinetics of TQB2825 by assessment of area under the plasma concentration time curve from the first dose to the last measurable concentration point.
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Area under the plasma concentration-time curve from time zero to time ∞(AUC0-∞)
To characterize the pharmacokinetics of TQB2825 by assessment of area under the plasma concentration time curve from the first dose to infinity.
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)
Cmin is the minimum plasma concentration of TQB2825
Time frame: Assessments were performed at fixed time points from Cycle 1 to Cycle 6, with each period being 28 days, about 6 months
Progress Free Survival(PFS)
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
Time frame: up to 96 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 96 weeks
Overall survival (OS)
the time from start of study treatment to date of death due to any cause
Time frame: up to 96 weeks