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

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT05664217
Trial Phases:	Phase II Phase III	Protocol IDs:	18-255-01 (primary) NCI-2023-02609
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Nektar
NCI Full Details:	http://clinicaltrials.gov/show/NCT05664217

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.

Objectives

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 study will be conducted in two stages: Stage 1 (Phase II) is expected to complete the
enrollment of 56 patients by the end of 2023. Primary endpoint data will be available in
the second half of 2024. Stage 2 (Phase III) is expected to initiate before the end of
2024.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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