Chiatai Tianqing Enrolls Subjects in a Clinical Study of TQB2223 Injection in Combination with Paanoprilumab for the Treatment of Lymphoma, Lung Cancer and Nasopharyngeal Carcinoma

May 15, 2024  Source: drugdu 30

"/Chiatai Tianqing Pharmaceutical Group Co., Ltd. is conducting a nationwide Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQB2223 Injection in combination with Paanoprilumab in subjects with advanced malignant tumors. The study has been approved by the State Drug Administration (Notification No. 2023LP00274) and passed the center's ethics, and is now recruiting nationwide.
Trial drug profile
TQB2223 injection is a lymphocyte activation gene-3 monoclonal antibody (LAG-3), registered as therapeutic biological product class 1. LAG-3, as an immune checkpoint, is expressed in activated T cells, NK cells, B cells and plasmacytoid dendritic cells, etc., and can negatively regulate T cells, which plays an important role in the maintenance of homeostasis of the body's immune system and the promotion of tumor immune escape. LAG-3 monoclonal antibody can block the LAG-3 ligand on the cell surface, enhance the secretion of cytokines and exert anti-tumor immunity.
Pavelizumab is a PD-1 monoclonal antibody, which has been approved and marketed with indications of classical Hodgkin's lymphoma, squamous non-small cell lung cancer, nasopharyngeal carcinoma, and so on.
Main Inclusion Criteria
1. Age 18~75 years old, gender is not limited;
2. Patients with relapsed or refractory classical Hodgkin's lymphoma and NK/T-cell lymphoma need to meet the following criteria: having received at least a second-line systemic systemic treatment regimen in the past and being resistant to PD-1 or PD-L1 monoclonal antibody;
3. patients with relapsed or refractory primary mediastinal large B-cell lymphoma need to meet:
- Relapse after autologous hematopoietic stem cell transplantation or have not achieved complete remission (C or partial remission within 60 days after surgery;
- Previous treatment with rituximab is required, or treatment with rituximab is not available for any reason;
4. patients with PD-L1-positive advanced non-small cell lung cancer (TPS ≥ 1%) are required to meet:
- Locally advanced (Stage IIIB/IIIC), recurrent, or metastatic (Stage IV) non-small cell lung cancer that is not amenable to surgical treatment and is not amenable to radical concurrent radiotherapy;
- No prior systemic antitumor therapy for advanced disease;
5. Patients with first-line recurrent or metastatic nasopharyngeal carcinoma who have not received systemic systemic therapy and have not received prior immune checkpoint inhibitors.
Main exclusion criteria
1. prior use of any other LAG-3 antibody analog;
2. prior grade 3 or higher immunotherapy-related adverse events;
3. a history of treatment requiring systemic therapy within 2 years prior to the first dose;
4. a diagnosis of immunodeficiency or ongoing treatment with systemic glucocorticoids or any other form of immunosuppressive therapy;
5. previous allogeneic hematopoietic stem cell transplantation.

By editor

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