A Phase Ib/II Clinical Trial of TQB3909 Tablets in Subjects With Relapsed or Refractory MCL Safety and Efficacy
This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed or refractory MCL.
• The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
• Age: ≥ 18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-2 points; Expected survival is more than 3 months;
• Subject population: Confirmed as MCL by local laboratory pathology and independent pathology review (stage 2).
• The main organs are functioning well,
• The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) shows measurable lesions, defined as ≥ 1 lymph node with the longest diameter of \> 1.5 cm or ≥ 1 extranodal lesion with the longest diameter of \> 1.0 cm, which can be measured by ≥ 2 vertical dimensions;
• Female subjects of childbearing age should agree to use contraception (e.g., pills, or condoms) during the study and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.