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)

Innovent Biologics

Status and phase: Unknown; Phase 1

Conditions: DLBCL

Treatments: Drug: IBI110; Drug: IBI110 plus sintilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039658

CIBI110B201

Details and patient eligibility

About

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.

Full description

This is a phase Ib, open-label, randomized study to determine the efficacy and safety of treatment with IBI110 single agent and in combination with sintilimab in DLBCL that are relapsed and/or refractory to available standard of care therapies.

Participants in each cohort are randomly assigned to one of the two arms: IBI110 single agent arm and IBI110 in combination with sintilimab arm. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Lugano 2014 Criteria for Malignant Lymphoma (Cheson et al 2014)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Single agent treatment arm with IBI110

Experimental group

Description:

IBI110 administered at RP2D

Treatment:

Drug: IBI110

Combination treatment arm with IBI10 and sintilimab

Experimental group

Description:

IBI110 and sintilimab administered at RP2D

Treatment:

Drug: IBI110 plus sintilimab