Tests TRS005 in adults with CD20-positive lymphoma that returned or did not respond

Who can take part

• ≥ 18 years, gender is not limited
• The participants need to undergo pathological biopsy of tumor tissue.. Confirmed by histopathology with CD20-positive DLBCL, except for High-grade B-cell lymphoma with MYC and BCL2 rearrangements (HGBL-DH), and histologic transformed DLBCL according to the WHO 2022 revised classification standards
• Relapse or refractory after at least 2 lines of sufficient standard treatment regimens
• Not considered to be eligible for Autologous Stem Cell Transplant (ASCT)
• Have measurable disease, including at least 1 nodal site measuring >1.5 cm or 1 extranodal site measuring >1.0 cm in longest dimension on computed tomography (CT)
• Previously received anti-tumor treatment such as radiotherapy, biotherapy, immunotherapy at least 28 days before the first administration of this study; chemotherapy at least 21 days before the first administration of this study; hormone therapy at least 14 days before the first administration of this study
• Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 (CTCAE 5.0) to prior anti-cancer therapy
• Organ Function Requirements：Adequate hematologic, renal, and hepatic function
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Participants must have a life expectancy of ≥3 months
• For women of childbearing potential and men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. For women of childbearing potential, a negative serum pregnancy test result within 7 days before the first administration
• All participants and/or their parents or legal guardians must sign a written informed consent form; Main Exclusion Criteria:
• A history of drug allergy to components of the test drug, xenoproteins, biological agents, etc., or severe infusion reaction after previous monoclonal antibody treatment
• Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load; Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load; Human immunodeficiency virus (HIV) seropositive
• Tumor-infiltrating diseases of the central nervous system
• Prior systemic treatment of lymphoma with MMAE-containing ADC drugs
• Prior treated with radiotherapy covering more than 30% of the bone marrow area
• ≥Grade 2 or greater baseline peripheral neuropathy
• Investigator-assessed diabetes uncontrolled by drug therapy
• Participants with other malignancies within the past 5 years
• Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath, etc.)
• Active of autoimmune disease or immune deficiency
• Accompanied significant cardiovascular disease
• Participants who received autologous stem cell transplantation and CAR-T within 3 months prior to first administration; Participants who have received allogeneic stem cell transplantation in the past
• Participants must not have an uncontrolled infection
• Various vaccines were inoculated within 28 days prior to first administration
• Participate in clinical trials of other drugs or medical devices within 28 days prior to first administration
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• Pregnancy and/or active Breast Feeding
• Investigators assessed as unsuitable to participate in this study for other reasons