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

• Status: Recruiting
• Trial end date: 2025-05-25
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

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.