NCT06290622

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL Post Chimeric Antigen Receptor T-cEll Therapy fAilUre (PLATEAU Study)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.

Conditions

• Diffuse Large B Cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	Retifanlimab, INCAGN02385, INCAGN02390	Treatment: Retifanlimab -infused over 60 minutes for C1D1 followed by a 60-minute observation period. If no infusion related reactions are observed infusion may be reduced to 30 minutes and no further observation period is needed for future cycles. If there is a reaction continue with 60 minute infusion and observation period for following cycle. Retifanlimab should always be administered first. INCAGN02385 and INCAGN02390 -individually administered over 30 minutes one after another. For first infusions of retifanlimab, INCAGN02385 and INCAGN02390, a 4 hour observation period is necessary after completion of all infusion. If no infusion related reactions are observed, for subsequent infusions no further observation period is needed for future cycles.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-06-30
• Completion: 2028-01-31
• First posted: 2024-03-04
• Last updated: 2025-05-06

Regulatory

• FDA-regulated drug study