Phase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological Malignancies

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

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)

Treatment groups

75 Participants
are divided into 1 treatment group