Clinical trial · Interventional
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)
A Phase Ib, Open Label, Randomized, Multicenter Study of the Efficacy and Safety of IBI110 Single Agent and in Combination With Sintilimab for Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)
NCT05039658CI-TRIAL-00053782unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI110 | Drug | — | UNRESOLVED |
| IBI110 plus sintilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single agent treatment arm with IBI110
- description
- IBI110 administered at RP2D
- interventionNames
- Drug: IBI110
- type
- EXPERIMENTAL
- label
- Combination treatment arm with IBI10 and sintilimab
- description
- IBI110 and sintilimab administered at RP2D
- interventionNames
- Drug: IBI110 plus sintilimab
Primary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.