Phase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological Malignancies (NCT07110194) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Clinical Trial of TQB2825 Subcutaneous Injection in CD20-positive Hematological Malignancies
China75 participantsStarted 2025-09
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Platelet count (PLT) ≥ 75 × 109/L (if accompanied by bone marrow invasion, platelet ≥ 50 × 109/L).
✓. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
✓. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If accompanied by liver metastasis, then ALT and AST ≤ 5 ULN;
✓. Serum creatinine (CR) ≤ 1.5 ULN or estimated glomerular filtration rate by Cockcroft-Gault formula ≥ 50 ml/min.
✓. Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5 × ULN (not receiving anticoagulant treatment);
Exclusion criteria
✕. 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;
What they're measuring
1
Peak time
Timeframe: Up to 4 month
2
Peak concentration Cmax
Timeframe: Up to 4 month
3
Plasma elimination half-life t1/2
Timeframe: Up to 4 month
Trial details
NCT IDNCT07110194
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
. Previously used other antibodies targeting both CD3 and CD20 for treatment;
✕. Received Chimeric Antigen Receptor T-cell (CAR-T) treatment, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first administration;