New 'Four-in-One' antibody takes on Hard-to-Treat lymphoma

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form; 2. No gender restrictions; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Patients with histologically confirmed non-Hodgkin's lymphoma; 6. Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL); 7. Presence of measurable lesions during the screening period (lymph node lesions with any long diameter ≥1.5 cm or extranodal lesions with any long diameter \>1.0 cm); 8. ECOG performance status score ≤2; 9. Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria; 10. Organ function levels meet the requirements before the first dose; 11. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose; 12. The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD); 2. Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.; 3. Active tuberculosis; 4. Patients with active autoimmune diseases; 5. History of other malignancies within 5 years prior to the first dose; 6. HBsAg-positive and/or HBcAb-positive with HBV-DNA levels ≥ the lower limit of detection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection; HIV antibody-positive; 7. Poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg); 8. History of severe cardiovascular or cerebrovascular diseases; 9. Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038; 10. Pregnant or lactating women; 11. Patients with central nervous system involvement; 12. Major surgery within 28 days before the first dose of this study or planned major surgery during the study period; 13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); 14. Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment; 15. Current use of immunosuppressive therapy; 16. Radiotherapy within 4 weeks before initiating GNC-038 treatment; 17. Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment; 18. CAR-T therapy within 12 weeks before initiating GNC-038 treatment; 19. Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study; 20. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.