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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)

Primary Purpose

DLBCL

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI110 plus sintilimab
IBI110
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DLBCL

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single agent treatment arm with IBI110

Combination treatment arm with IBI10 and sintilimab

Arm Description

IBI110 administered at RP2D

IBI110 and sintilimab administered at RP2D

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
Percentage of subjects achieving complete remission and partial remission in the studied cohort
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.

Secondary Outcome Measures

complete response rate
The percentage of subjects that achieved complete response in the studied cohort
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.
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.
OS
OS is defined as the time from treatment to the date of death.

Full Information

First Posted
September 1, 2021
Last Updated
September 1, 2021
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05039658
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 27, 2021 (Anticipated)
Primary Completion Date
July 12, 2022 (Anticipated)
Study Completion Date
December 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DLBCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single agent treatment arm with IBI110
Arm Type
Experimental
Arm Description
IBI110 administered at RP2D
Arm Title
Combination treatment arm with IBI10 and sintilimab
Arm Type
Experimental
Arm Description
IBI110 and sintilimab administered at RP2D
Intervention Type
Drug
Intervention Name(s)
IBI110 plus sintilimab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IBI110
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Percentage of subjects achieving complete remission and partial remission in the studied cohort
Time Frame
Up to 24 months
Title
The frequency of adverse events (adverse events, AEs) and serious adverse events (SAEs)
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
complete response rate
Description
The percentage of subjects that achieved complete response in the studied cohort
Time Frame
Up to 24 months
Title
DoR
Description
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.
Time Frame
Up to 24 months
Title
PFS
Description
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.
Time Frame
Up to 24 months
Title
OS
Description
OS is defined as the time from treatment to the date of death.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yong wang
Phone
0512-69566088
Email
yong.wang@innoventbio.com
Facility Information:
Facility Name
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, PhD, MD
Phone
021-64370045
Email
zwl_trial@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

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