A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma

Exclusion Criteria

• •A patient who conforms to any of the following criteria should be excluded from the study:
• •1. Any prior therapy with an bispecific antibody of the same class
• •2. Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)
• •3. Known central nervous system (CNS) involvement by lymphoma
• •4. Known past or current malignancy other than inclusion diagnosis, with the following exceptions:
• •1. Cervical carcinoma of Stage Ib or less
• •2. Non-invasive basal cell or squamous cell skin carcinoma
• •3. Non-invasive, superficial bladder cancer
• •4. Prostate cancer with a current prostate-specific antigen (PSA) level \<0.1 ng/mL
• •5. Any curable cancer with a complete response (CR) of \>2 years duration
• •5. Known clinically significant cardiac disease, including:
• •1. Onset of unstable angina pectoris or acute myocardial infarction within 6 months prior to signing Informed Consent Form (ICF)
• •2. Congestive heart failure prior to signing ICF (meets the criteria of New York Heart Association Classification III or IV)
• •3. Clinically significant arrhythmia prior to signing ICF
• •6. History of interstitial lung disease or uncontrolled lung diseases, or evidence of dyspnea at rest or pulse oximetry \< 93% while breathing room air.
• •7. Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (including \>20mg/day prednisolone \[or equivalent\], but low-dose prednisolone is allowed). The well controlled autoimmune disease can be enrolled at investigator's discretion, including:
• •1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone
• •2. Patients with a history of type 1 diabetes mellitus who were well controlled (defined as a screening hemoglobin A1c \< 8% and no urinary ketoacidosis)
• •3. Patients with skin disease who were not treated with systemic corticosteroid
• •8. History of seizure disorder or confirmed progressive multifocal leukoencephalopathy (PML)
• •9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
• •10. Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks prior to signing ICF
• •11. Positive for human immunodeficiency virus (HIV) antibody. Positive for hepatitis B antibody (except for only the positive HBsAb) with detectable hepatitis B virus (HBV) DNA. Positive for hepatitis C antibody with detectable hepatitis C virus (HCV) RNA
• •12. Chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration (only applicable for dose-expansion phase)
• •13. Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation
• •14. Received major surgery within 4 weeks prior to first SCTB35 administration, or planned to receive major surgery during the study
• •15. Received any chemotherapeutic agent, other anti-cancer agent, or investigational drug (monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first SCTB35 administration
• •16. Exposed to live or live attenuated vaccine within 4 weeks prior to first SCTB35 administration, or planned to receive these vaccines during the study
• •17. Pregnancy or breast feeding. During the study and for 6 months after last administration of SCTB35, a woman of childbearing potential or a man who is sexually active with a woman of childbearing potential disagrees to practice a highly effective method of birth control.
• •18. Patient has any condition for that, in the opinion of the investigator, participation could prevent, limit, or confound the protocol-specified assessments