Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 3:04 PM
Study NCT ID:
NCT05039658
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2021-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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)
Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Organization:
Study Overview
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)
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: