The aim of this study is to evaluate the pharmacokinetic characteristics, safety and efficacy of the TQB2825 injection (subcutaneous administration) in patients with CD20-positive hematological malignancies.
The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
Age 18 years or older and less than 80 years (calculated based on the date of signing the informed consent form);
Eastern Cooperative Oncology Group (ECOG) score 0 to 2 points;
Expected survival greater than 12 weeks;
Within the 5 years prior to the first medication administration, the subject had or currently has other malignant tumors. The following two situations can be included in the study: other malignant tumors treated by a single surgical procedure, achieving 5 consecutive years of disease-free survival (DFS); cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (in situ cancer), and T1 (tumor infiltration of the basement membrane)];
Previous treatment-induced adverse reactions have not recovered to a Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5.0) score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, stable thyroid function hypofunction after hormone replacement therapy, etc., which are judged by the investigator to have no safety risks;
Within 4 weeks before the first administration, received chemotherapy, immunotherapy, monoclonal antibody treatment, radiation therapy within 2 weeks, or small molecule targeted drugs, or still within the 5 half-lives of the drug (based on the earliest occurrence time), calculate the washout period from the end of the last treatment;
Treatment with Chinese patent medicines (including Compound Banmao Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Yadanzi Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.) that are explicitly approved by the National Medical Products Administration (NMPA) with anti-tumor indications in the package insert within 2 weeks prior to the first dose;
Single group
TQB2825 Injection (Subcutaneous Injection)
DrugTQB2825 is a Cluster of Differentiation 3 × Cluster of Differentiation 20 (CD3×CD20) dual antibody, which can simultaneously target the CD20 on tumor cells and the CD3 on T cells. It can induce T cell activation, proliferation and cytokine release, and effectively target and kill tumor cells.
Peak time
Time to peak blood concentration after a single dose
Peak concentration Cmax
After a single dose, the highest point of the drug-time curve is called the peak concentration.
Plasma elimination half-life t1/2
The amount of time it takes for the concentration of the drug in the blood, or the amount of drug in the body, to drop to about half of its original level.
Incidence and severity of AE and Serious Adverse Event (SAE), and abnormal laboratory test indicators
Incidence and severity of AE and SAE, and abnormal laboratory test indicators
Overall response rate
To assess the percentage of patients with complete (CR) or partial response (PR) in the CD20-positive hematological tumor population who received the TQB2825 subcutaneous injection.
Complete response rate
To evaluate the percentage of complete response (CR) achieved by the subcutaneous injection of TQB2825 in patients with CD20-positive hematological malignancies.
Progression-free survival period
To evaluate the progression-free survival of TQB2825 subcutaneous injection in patients with CD20-positive hematological malignancies.
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