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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• Lymphoma, Large B-Cell, Diffuse 1,389

Lymphoma, Large B-Cell, Diffuse

1,389 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 349 are open to participants now.

This study's planned enrollment of 50 is close to the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Study arms

• Experimental
  Single agent treatment arm with IBI110

  IBI110 administered at RP2D

  Drug: IBI110

• Experimental
  Combination treatment arm with IBI10 and sintilimab

  IBI110 and sintilimab administered at RP2D

  Drug: IBI110 plus sintilimab

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.

Primary outcomes

1. Objective response rate (ORR)

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

   Time frame: Up to 24 months

2. 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.

   Time frame: Up to 24 months

Secondary outcomes

1. complete response rate

   The percentage of subjects that achieved complete response in the studied cohort

   Time frame: Up to 24 months

2. 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.

   Time frame: Up to 24 months

3. 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.

   Time frame: Up to 24 months

4. OS

   OS is defined as the time from treatment to the date of death.

   Time frame: Up to 24 months

Individual participant data

Plan to share: No