Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

• Status: Not yet recruiting
• Trial end date: 2022-12-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether treatment with IBI110 single agent and in combination with sintilimab demonstrates sufficient efficacy/safety in r/r DLBCL.

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

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

• Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

• Male or female, 18-70 years old (at the time consent is obtained)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Histologically confirmed diagnosis of DLBCL in a subject who has been pretreated with at least 2 lines of systematic treatment (regimens containing anthracyclines and anti-CD20 immunotherapy must be included);

• Subjects whose most recent therapy was CAR-T cell therapy were also eligible.

Exclusion Criteria:

Patients previously exposed to any anti-LAG-3 treatment.

• History of ≥Grade 3 CRS, neurotoxicity, or hemophagocytic lymphohistiocytosis) during previous CAR-T cell therapy.

• Impaired cardiac function or clinically significant cardiac disease.

• Active, known or suspected autoimmune disease or a documented history of autoimmune disease within two years prior to screening with a few exceptions as per protocol.