Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
CD20-positive B-cell Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for CD20-positive B-cell Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria: Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL). At least one measurable or assessable tumor lesion. Adequate organ and hematologic function. Eastern Co-operative Oncology Group (ECOG) score 0 to 2. All adverse events from prior treatment must be CTCAE v5.0 grade <= 1 Exclusion Criteria: Active central nervous system (CNS) lymphoma. Systemic steroid therapy (dose equivalent to > 10 mg prednisone / day). History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade >=3). Have evidence of severe uncontrollable active infection. Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Experimental
IMM0306 Monotherapy
Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level. Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part.