NCT05664217

NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma

A Phase 2/3, Randomized, Double Blind, Placebo-controlled, Multicenter Study of NKTR-255 vs Placebo Following CD19-directed CAR-T Cell Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of NKTR-255 following CD19-directed chimeric antigen (CAR)-T cell therapy in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL). NKTR-255 is an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer. T cells are infection fighting blood cells that can kill tumor cells. Chimeric antigen (CAR)-T cell product consists of genetically engineered T-cells, modified to recognize CD19, a protein on the surface of cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19-positive cancer cells. Giving NKTR-255 following the treatment with CD19 CAR-T cell therapy may work better in treating large B-cell lymphoma than either drug alone.

Detailed description

Patients will be treated with lymphodepletion chemotherapy (as recommended by the CAR-T cell manufacturer) and soon after will receive a one-time CD19-directed CAR-T cell infusion (as per product label). Study drug (NKTR-255 or placebo) will be administered intravenously approximately 14 days after CAR-T cell infusion and administered every 3 weeks for up to 7 cycles or 5 months (whichever is earlier) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed-up at 30 days, and then at 9,12,18, 24, and 36 months after CAR-T cell infusion. The Stage 1 (Phase II) portion of the study only enrolled to the dose optimization. Primary endpoint data will be available in the second half of 2024.

Conditions

• Non-Hodgkin Lymphoma
• Relapsed/Refractory Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	NKTR-255 at 1.5 µg/kg	NKTR-255 at 1.5 µg/kg
DRUG	NKTR-255 at 3.0 μg/kg	NKTR-255 at 3.0 μg/kg
DRUG	NKTR-255 at 3.0/6.0 μg/kg	NKTR-255 at 3.0/6.0 μg/kg
OTHER	Placebo Comparator	Commercially available 0.9% Sodium Chloride Solution for Injection (USP)

Timeline

• Start date: 2022-12-23
• Primary completion: 2024-05-22
• Completion: 2024-08-16
• First posted: 2022-12-23
• Last updated: 2025-02-13

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study