Phase I/II Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma

IMM0306-I

This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).

2020-03-02

2025-05-25

2025-05-25

Recruiting

Early phase I

154

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 154, 'type': 'ESTIMATED'}}

2023-04-10