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)

DLBCL Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05039658
• Other study ID #: CIBI110B201
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: September 2021
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: yong wang
• Phone: 0512-69566088
• Email: yong.wang[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• DLBCL
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• IBI110 plus sintilimab
Sintilimab is a NMPA approved high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
• IBI110
BI110 is a high-affinity, ligand-blocking, humanized anti- Lymphocyte Activation Gene-3 (LAG-3) IgG4 antibody that blocks the binding of LAG-3 to MHCII.

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Percentage of subjects achieving complete remission and partial remission in the studied cohort	Up to 24 months
Primary	The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)	An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE were defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.	Up to 24 months
Secondary	complete response rate	The percentage of subjects that achieved complete response in the studied cohort	Up to 24 months
Secondary	DoR	DOR is defined as the date of their first objective response (which is subsequently confirmed) to disease progression per the the Lugano 2014 criteria or death regardless of cause.	Up to 24 months
Secondary	PFS	PFS is defined as the time from the treatment date to the date of disease progression per Lugano 2014 criteria or death regardless of cause.	Up to 24 months
Secondary	OS	OS is defined as the time from treatment to the date of death.	Up to 24 months