DLBCL
Conditions
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.
Interventions
DRUGIBI110 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.
DRUGIBI110
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.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 24 months | 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) | Up to 24 months | 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
| Measure | Time frame | Description |
|---|---|---|
| PFS | Up to 24 months | 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 | Up to 24 months | OS is defined as the time from treatment to the date of death. |
| complete response rate | Up to 24 months | The percentage of subjects that achieved complete response in the studied cohort |
| DoR | Up to 24 months | 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. |
Countries
China
Contacts
Primary Contactyong wang
Outcome results
None listed