About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- TQB2825 Injection (Subcutaneous Injection)