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)

NCT05039658 | Unknown Phase 1

• 1 other identifier: CIBI110B201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

DLBCL

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  Percentage of subjects achieving complete remission and partial remission in the studied cohort

  Up to 24 months

• 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 Outcomes (4)

• complete response rate

  Up to 24 months

• DoR

  Up to 24 months

• PFS

  Up to 24 months

• OS

  Up to 24 months

Study Arms (2)

Single agent treatment arm with IBI110

EXPERIMENTAL

IBI110 administered at RP2D

Drug: IBI110

Combination treatment arm with IBI10 and sintilimab

EXPERIMENTAL

IBI110 and sintilimab administered at RP2D

Drug: IBI110 plus sintilimab

Interventions

IBI110 plus sintilimab DRUG

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.

Combination treatment arm with IBI10 and sintilimab

IBI110 DRUG

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.

Single agent treatment arm with IBI110

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Interventions

sintilimab

Central Study Contacts

yong wang

CONTACT

0512-69566088; yong.wang@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: September 27, 2021
• Primary Completion: July 12, 2022
• Study Completion: December 2, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)